Sorafenib With Either Temsirolimus or Tipifarnib in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed By Surgery

May 2, 2014 updated by: National Cancer Institute (NCI)

A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) With Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma

This randomized phase II trial is studying how well giving sorafenib together with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known whether sorafenib is more effective when given together with temsirolimus or tipifarnib in treating patients with malignant melanoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Compare the response rate (confirmed and unconfirmed and complete and partial) in patients with unresectable stage IV malignant melanoma treated with sorafenib in combination with either temsirolimus or tipifarnib.

II. Compare the 4-month progression-free survival rate of patients treated with these regimens.

III. Compare the safety and tolerability of these regimens, with an emphasis on long-term side effects and toxic effects, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastatic (M) stage (M1a/b vs M1c). Patients are randomized to 1 of 2 treatment arms.

ARM I (reopened to accrual as of 8/15/2009): Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.

ARM II (closed to accrual as of 8/15/2009): Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

Study Type

Interventional

Enrollment (Actual)

109

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

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Castro Valley, California, United States, 94546
        • Eden Hospital Medical Center
      • Castro Valley, California, United States, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, United States, 94546
        • Valley Medical Oncology Consultants-Castro Valley
      • Fremont, California, United States, 94538
        • Valley Medical Oncology Consultants-Fremont
      • Los Angeles, California, United States, 90033
        • University of Southern California/Norris Cancer Center
      • Martinez, California, United States, 94553-3156
        • Contra Costa Regional Medical Center
      • Mountain View, California, United States, 94040
        • El Camino Hospital
      • Oakland, California, United States, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, United States, 94609
        • Bay Area Tumor Institute CCOP
      • Oakland, California, United States, 94602
        • Highland General Hospital
      • Oakland, California, United States, 94609
        • Bay Area Breast Surgeons Inc
      • Oakland, California, United States, 94609
        • Larry G Strieff MD Medical Corporation
      • Oakland, California, United States, 94609
        • Tom K Lee Inc
      • Pleasanton, California, United States, 94588
        • Valley Care Health System - Pleasanton
      • Pleasanton, California, United States, 94588
        • Valley Medical Oncology Consultants
      • Roseville, California, United States, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, United States, 95816
        • Sutter General Hospital
      • San Pablo, California, United States, 94806
        • Doctors Medical Center- JC Robinson Regional Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Exempla Saint Joseph Hospital
      • Denver, Colorado, United States, 80224-2522
        • Colorado Cancer Research Program CCOP
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Grand Junction, Colorado, United States, 81502
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80033
        • Exempla Lutheran Medical Center
    • Florida
      • Leesburg, Florida, United States, 34788
        • Cancer Centers of Central Florida PA
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Savannah, Georgia, United States, 31403
        • Memorial Health University Medical Center
      • Valdosta, Georgia, United States, 31603
        • South Georgia Medical Center
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush - Copley Medical Center
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates Limited
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Moline, Illinois, United States, 61265
        • Garneau, Stewart C MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Porubcin, Michael MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Sharis, Christine M MD (UIA Investigator)
      • Moline, Illinois, United States, 61265
        • Stoffel, Thomas J MD (UIA Investigator)
      • Springfield, Illinois, United States, 62781-0001
        • Memorial Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Urbana, Illinois, United States, 61801
        • Carle Clinic-Urbana Main
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Franciscan Saint Anthony Health-Michigan City
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC-William R Bliss Cancer Center
      • Bettendorf, Iowa, United States, 52722
        • Constantinou, Costas L MD (UIA Investigator)
      • Clive, Iowa, United States, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Davenport, Iowa, United States, 52803
        • Genesis Medical Center - East Campus
      • Davenport, Iowa, United States, 52804
        • Genesis Medical Center - West Campus
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Des Moines, Iowa, United States, 50307
        • Mercy Capitol
      • Des Moines, Iowa, United States, 50309
        • Iowa Oncology Research Association CCOP
      • Sioux City, Iowa, United States, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology Oncology Associates
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center-Sioux City
    • Kansas
      • Anthony, Kansas, United States, 67003
        • Hospital District Sixth of Harper County
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Hays, Kansas, United States, 67601
        • Hays Medical Center
      • Hutchinson, Kansas, United States, 65702
        • Promise Regional Medical Center-Hutchinson
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Kansas City, Kansas, United States, 66112
        • Providence Medical Center
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Olathe, Kansas, United States, 66061
        • Olathe Cancer Center
      • Overland Park, Kansas, United States, 66210
        • Radiation Oncology Practice Corporation Southwest
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Topeka, Kansas, United States, 66606
        • Saint Francis Hospital and Medical Center - Topeka
      • Topeka, Kansas, United States, 66604
        • Stormont-Vail Regional Health Center
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67208
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Main Office
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67214
        • Wichita CCOP
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Louisiana
      • Monroe, Louisiana, United States, 71210
        • Louisiana State University Sciences Center- Monroe
      • Shreveport, Louisiana, United States, 71105
        • Highland Clinic
      • Shreveport, Louisiana, United States, 71130
        • Louisiana State University Health Sciences Center Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Big Rapids, Michigan, United States, 49307
        • Spectrum Health Big Rapids Hospital
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, United States, 49503
        • Mercy Health Saint Mary's
      • Grand Rapids, Michigan, United States, 49503
        • Grand Rapids Clinical Oncology Program
      • Holland, Michigan, United States, 49423
        • Holland Community Hospital
      • Muskegon, Michigan, United States, 49444
        • Mercy Health Mercy Campus
      • Muskegon, Michigan, United States, 49442
        • Mercy Health Partners-Hackley Campus
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital
    • Minnesota
      • Litchfield, Minnesota, United States, 55355
        • Meeker County Memorial Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute
    • Missouri
      • Cape Girardeau, Missouri, United States, 63701
        • Southeast Missouri Hospital
      • Independence, Missouri, United States, 64057
        • Centerpoint Medical Center LLC
      • Kansas City, Missouri, United States, 64114
        • Radiation Oncology Practice Corporation South
      • Kansas City, Missouri, United States, 64154
        • Radiation Oncology Practice Corporation - North
    • Montana
      • Billings, Montana, United States, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, United States, 59101
        • Montana Cancer Consortium CCOP
      • Billings, Montana, United States, 59102
        • Hematology-Oncology Centers of the Northern Rockies PC
      • Billings, Montana, United States, 59107-7000
        • Billings Clinic
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, United States, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Havre, Montana, United States, 59501
        • Northern Montana Hospital
      • Helena, Montana, United States, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, United States, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, United States, 59901
        • Kalispell Medical Oncology
      • Missoula, Montana, United States, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, United States, 59801
        • Community Medical Hospital
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
    • Nebraska
      • Kearney, Nebraska, United States, 68847
        • Good Samaritan Hospital
      • Lincoln, Nebraska, United States, 68510
        • Nebraska Cancer Research Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89106
        • Nevada Cancer Research Foundation CCOP
    • New York
      • Cooperstown, New York, United States, 13326
        • Mary Imogene Bassett Hospital
      • Middletown, New York, United States, 10940
        • Orange Regional Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital-Memorial Campus
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Mansfield, Ohio, United States, 44903
        • Mansfield General Hospital-MedCentral Health System
    • Oregon
      • Portland, Oregon, United States, 97216
        • Adventist Medical Center
      • Portland, Oregon, United States, 97239
        • SWOG
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States, 19026
        • Delaware County Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Hospital
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Medical Center
      • Spartanburg, South Carolina, United States, 29303
        • Upstate Carolina CCOP
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Regional Medical Center
      • Norton, Virginia, United States, 24273
        • Southwest VA Regional Cancer Center
    • Washington
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, United States, 98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Kennewick, Washington, United States, 99336
        • Columbia Basin Hematology and Oncology PLLC
      • Mount Vernon, Washington, United States, 98274
        • Skagit Valley Hospital
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98104
        • Minor and James Medical PLLC
      • Seattle, Washington, United States, 98112
        • Group Health Cooperative-Seattle
      • Seattle, Washington, United States, 98122-4307
        • Swedish Medical Center-First Hill
      • Seattle, Washington, United States, 98122
        • The Polyclinic
      • Sedro-Woolley, Washington, United States, 98284
        • United General Hospital
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • Dean Hematology and Oncology Clinic
    • Wyoming
      • Sheridan, Wyoming, United States, 82801
        • Welch Cancer 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

Genders Eligible for Study

All

Description

Criteria:

  • Histologically confirmed malignant melanoma of cutaneous origin
  • Patients with unknown primary allowed
  • Stage IV disease
  • Measurable disease by physical examination, CT scan, MRI or plain x-ray
  • Unresectable disease
  • Residual or recurrent disease after prior surgery for stage IV disease allowed
  • Residual tumor at the site of incomplete resection may be included only as nonmeasurable disease
  • Must have serum lactate dehydrogenase (LDH) levels measured
  • Must have tissue specimens available
  • Negative brain CT scan or MRI within the past 42 days
  • Creatinine =< 1.5 times ULN
  • Absolute neutrophil count >= 1,000/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 9.0 g/dL
  • Fasting cholesterol =< 350 mg/dL (lipid-lowering agents allowed)
  • Triglycerides =< 300 mg/dL (lipid-lowering agents allowed)
  • No symptomatic sensory neuropathy >= grade 2
  • No evidence of bleeding diathesis or coagulopathy
  • No congestive heart failure
  • No myocardial infarction within the past 2 months
  • No New York Heart Association class III or IV heart disease
  • No condition that impairs the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedure affecting absorption, or active peptic ulcer disease)
  • No known allergy to imidazoles (e.g. clotrimazole, ketoconazole, miconazole, or econazole)
  • No history of allergic reaction to compounds of similar chemical or biologic composition as tipifarnib
  • No hypertension with systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg
  • Patients with well-controlled hypertension allowed
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled diabetes
  • No uncontrolled diabetes
  • No active uncontrolled infection
  • No other severe or uncontrolled medical disease
  • No psychologic or medical condition that would preclude study treatment or compliance
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer that is in complete remission, or carcinoma in situ of the cervix
  • At least 90 days since prior adjuvant therapy, including cytotoxic agents
  • At least 28 days since prior radiotherapy
  • At least 28 days since prior surgery to remove the tumor
  • No prior systemic therapy for stage IV melanoma
  • No prior therapy with agents targeting farnesyl transferase, the MAP kinase pathway, or vascular endothelial growth factors (VEGF) or receptors (VEFGR), including drugs such as sorafenib, temsirolimus, or tipifarnib
  • Concurrent lipid-lowering agents allowed
  • Not requiring full-dose anticoagulation for recent thrombotic event
  • No concurrent highly active antiretroviral therapy (HAART) in HIV-positive patients
  • No concurrent use of any of the following: dilantin; carbamazepine; Phenobarbital; rifampin; hypericum perforatum (St. John's wort); ketoconazole; itraconazole; ritonavir; cyclosporine; phenytoin; grapefruit juice
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT =< 2.5 times ULN (5 times ULN if hepatic metastases)
  • No history of brain metastases
  • Zubrod performance status 0-1

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (sorafenib, temsirolimus)
Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
Drug: sorafenib tosylate
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Drug: temsirolimus
Given IV
Other Names:
  • Torisel
  • CCI-779
  • cell cycle inhibitor 779
Experimental: Arm II (sorafenib, tipifarnib)
Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
Drug: tipifarnib
Given orally
Other Names:
  • R115777
  • Zarnestra
Drug: sorafenib tosylate
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (Complete and Partial)
Time Frame: Every 8 weeks until progression
Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30fi decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.
Every 8 weeks until progression
4-month Progression-free Survival
Time Frame: 4 months after registration
Progression was defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesions, death due to disease without prior documentation of progression and without symptomatic deterioration.
4 months after registration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-year Overall Survival
Time Frame: One year after registration
One year after registration
Toxicity
Time Frame: Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

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

August 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 24, 2006

First Submitted That Met QC Criteria

January 24, 2006

First Posted (Estimate)

January 25, 2006

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 2, 2014

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2009-00774 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA032102 (U.S. NIH Grant/Contract)
  • S0438 (Other Identifier: CTEP)
  • CDR0000454925

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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