Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer

June 14, 2023 updated by: Eastern Cooperative Oncology Group

A Double Blind Phase II Study of BAY 43-9006 in Patients With Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens

RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib.

PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To determine the percent of patients maintaining stable disease or objective response two months after randomization with continued sorafenib treatment, compared to patients switched to placebo.
  • To determine progression-free survival, overall survival, and response rate.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to number of prior chemotherapy regimens (2 vs more than 2) and prior epidermal growth factor receptor inhibitor treatment (yes vs no).

  • Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.
  • Randomization: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive oral sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity.
    • Arm II: Patients receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients who develop disease progression within 1 year after randomization cross over to arm I.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 311 patients will be accrued for this study within approximately 3 years.

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Stanford, California, United States, 94305
        • Stanford Comprehensive Cancer Center - Stanford
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Presbyterian Hospital
      • Boulder, Colorado, United States, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, United States, 80218
        • St. Joseph Hospital
      • Denver, Colorado, United States, 80224-2522
        • CCOP - Colorado Cancer Research Program
      • Englewood, Colorado, United States, 80110
        • Swedish Medical Center
      • Fort Collins, Colorado, United States, 80528
        • Front Range Cancer Specialists
      • Grand Junction, Colorado, United States, 81502
        • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80502
        • Hope Cancer Care Center at Longmont United Hospital
      • Pueblo, Colorado, United States, 81004
        • St. Mary - Corwin Regional Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Cancer Institute - Jacksonville
    • Illinois
      • Aurora, Illinois, United States, 60507
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, United States, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Graham Hospital
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Radiation Oncology
      • Eureka, Illinois, United States, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Clinic, PC
      • Harvey, Illinois, United States, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Hematology Oncology Associates
      • Hopedale, Illinois, United States, 61747
        • Hopedale Medical Complex
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Kewanee, Illinois, United States, 61443
        • Kewanee Hospital
      • Macomb, Illinois, United States, 61455
        • Mcdonough District Hospital
      • Normal, Illinois, United States, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, United States, 61761
        • Community Cancer Center
      • Ottawa, Illinois, United States, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, United States, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, United States, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61614
        • Proctor Hospital
      • Peoria, Illinois, United States, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, United States, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, United States, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Rockford, Illinois, United States, 61104-2315
        • Swedish-American Regional Cancer Center
      • Spring Valley, Illinois, United States, 61362
        • St. Margaret's Hospital
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Kokomo, Indiana, United States, 46904
        • Howard Community Hospital
      • La Porte, Indiana, United States, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Lafayette, Indiana, United States, 47904
        • Clarian Arnett Cancer Care
      • Michigan City, Indiana, United States, 46360
        • Saint Anthony Memorial Health Centers
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, United States, 46617
        • Saint Joseph Regional Medical Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Cedar Rapids Oncology Associates
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center - Sioux City
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal, Kansas, United States, 67901
        • Southwest Medical Center
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Massachusetts
      • Taunton, Massachusetts, United States, 02780
        • Morton Hospital & Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Jackson, Michigan, United States, 49201
        • Foote Hospital
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Robbinsdale, Minnesota, United States, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Somerville, New Jersey, United States, 08876
        • Somerset Medical Center
    • New York
      • Bronx, New York, United States, 10466
        • Our Lady of Mercy Medical Center Comprehensive Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44710-1799
        • Aultman Cancer Center at Aultman Hospital
      • Cincinnati, Ohio, United States, 45219
        • Christ Hospital Cancer Center
      • Cleveland, Ohio, United States, 44106-5065
        • Case Comprehensive Cancer Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Cancer Care Center at MetroHealth Medical Center
      • Lima, Ohio, United States, 45801
        • St. Rita's Medical Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Cancer Network at St. Luke's Hospital
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, United States, 17822-0001
        • Geisinger Medical Center
      • Easton, Pennsylvania, United States, 18042
        • Easton Regional Cancer Center at Easton Hospital
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Lemoyne, Pennsylvania, United States, 17043
        • Central Pennsylvania Hematology and Medical Oncology Associates, PC
      • Lewistown, Pennsylvania, United States, 17044
        • Lewistown Hospital
      • Paoli, Pennsylvania, United States, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Joan Karnell Cancer Center at Pennsylvania Hospital
      • State College, Pennsylvania, United States, 16803
        • Mount Nittany Medical Center
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group - Scenery Park
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center, PC
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37901
        • Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Dallas, Texas, United States, 75235
        • UT Southwestern University Hospital - Zale Lipshy
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911-3496
        • Fox Valley Hematology and Oncology - East Grant Street
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Madison, Wisconsin, United States, 53717
        • Dean Medical Center - Madison
      • Manitowoc, Wisconsin, United States, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic - Marshfield Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC)
  • Disease must have progressed after at least 2 prior chemotherapy regimens for NSCLC
  • Patients must have measurable or nonmeasurable disease
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 3 times ULN (5 times ULN in patients with liver disease)
  • Creatinine less than 1.5 times ULN or calculated creatinine clearance greater than 50 mL/min
  • More than 3 weeks since prior chemotherapy, radiotherapy, immunotherapy or other investigational drug use
  • Recovered from all prior therapy
  • Fertile patients must use effective contraception
  • Age >= 18
  • ECOG performance status of 0-1

Exclusion Criteria:

  • Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable and off therapy for at least 2 months
  • Active second malignancy
  • Clinically evident congestive heart failure, serious cardiac arrhythmias, or symptoms of coronary heart disease
  • Prior radiotherapy to the only site of measurable or evaluable disease unless there is evidence of disease progression in that site
  • Prior exposure to a ras pathway inhibitor (e.g., farnesyl transferase inhibitor)
  • Concurrent medications known to be metabolized by the liver with a narrow therapeutic index, including the following:

    • Ketoconazole
    • Itraconazole
    • Quinidine
    • Digoxin
    • Cyclosporine
    • Ritonavir
    • Grapefruit products
    • Carbamazepine
    • Phenytoin
    • Phenobarbital
  • Pregnant or nursing
  • Clinically serious active infection
  • Medical conditions, substance abuse or psychological/social situation that would preclude study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction then Sorafenib

Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.

Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.

Step 1 (induction): Sorafenib was giventwice daily for two cycles to all patients. Patients with progression (PD) discontinued treatment. Those who responded after two cycles continued treatment up to 1 year or until PD. With response after 1 year, patients were given the option to continue treatment until PD. Patients who were stable after the end of induction were then randomized onto Step 2 to either continue sorafenib or receive placebo.

Step 2 (randomization): Patients with stable disease after induction will be randomized in a double-blinded manner to placebo or sorafenib. If a patient has progressed, the arm will be unblinded. Patients on placebo with PD can then crossover to receive sorafenib; patients with PD on the sorafenib arm will be removed from the study.

Step 3 (crossover): If patients on placebo progressed within 1 year from randomization, they crossed over to the treatment arm and receive sorafenib for up to 1 year or until PD, unacceptable toxicity, or death.

Other Names:
  • BAY 43-9006
  • Nexavar
Placebo Comparator: Induction then Placebo then Sorafenib

Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.

Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm.

Step 1 (induction): Sorafenib was giventwice daily for two cycles to all patients. Patients with progression (PD) discontinued treatment. Those who responded after two cycles continued treatment up to 1 year or until PD. With response after 1 year, patients were given the option to continue treatment until PD. Patients who were stable after the end of induction were then randomized onto Step 2 to either continue sorafenib or receive placebo.

Step 2 (randomization): Patients with stable disease after induction will be randomized in a double-blinded manner to placebo or sorafenib. If a patient has progressed, the arm will be unblinded. Patients on placebo with PD can then crossover to receive sorafenib; patients with PD on the sorafenib arm will be removed from the study.

Step 3 (crossover): If patients on placebo progressed within 1 year from randomization, they crossed over to the treatment arm and receive sorafenib for up to 1 year or until PD, unacceptable toxicity, or death.

Other Names:
  • BAY 43-9006
  • Nexavar
Patients randomized to the placebo arm in step 2 continued receiving placebo until disease progression or one year from randomization. Placebo was given orally twice a day (BID).
Other: Induction, not randomized

Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.

Post-induction: Patients with responding disease or disease progression were not randomized in Step 2. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression, while patients with disease progression were removed from the study.

Step 1 (induction): Sorafenib was giventwice daily for two cycles to all patients. Patients with progression (PD) discontinued treatment. Those who responded after two cycles continued treatment up to 1 year or until PD. With response after 1 year, patients were given the option to continue treatment until PD. Patients who were stable after the end of induction were then randomized onto Step 2 to either continue sorafenib or receive placebo.

Step 2 (randomization): Patients with stable disease after induction will be randomized in a double-blinded manner to placebo or sorafenib. If a patient has progressed, the arm will be unblinded. Patients on placebo with PD can then crossover to receive sorafenib; patients with PD on the sorafenib arm will be removed from the study.

Step 3 (crossover): If patients on placebo progressed within 1 year from randomization, they crossed over to the treatment arm and receive sorafenib for up to 1 year or until PD, unacceptable toxicity, or death.

Other Names:
  • BAY 43-9006
  • Nexavar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Maintaining Stable Disease or Objective Response 2 Months After Randomization
Time Frame: Two months after randomization

Per RECIST Criteria (V1.0):

Complete Response (CR): disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions Progressive Disease (PD): >=20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of longest diameter recorded since randomization, or the appearance of new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

Two months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years.
Progression-free survival is defined as the duration from randomization to disease progression or death, whichever occurs first. Only randomized patients were included in this analysis.
Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years.
Overall Survival
Time Frame: Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years
Overall survival is defined as the duration from randomization to death or last known alive. Only randomized patients were included in this analysis.
Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years
Best Overall Response
Time Frame: Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years
The best overall response is the best response (per RECIST 1.0) recorded from randomization until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since randomization.
Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Joan H. Schiller, MD, Simmons Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2004

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

July 8, 2003

First Submitted That Met QC Criteria

July 8, 2003

First Posted (Estimated)

July 9, 2003

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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