Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

June 28, 2016 updated by: Alliance for Clinical Trials in Oncology

A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy.

PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without dimesna.
  • Compare the feasibility of these regimens, in terms of febrile neutropenia and treatment delays, in these patients.
  • Compare the objective response rate in patients treated with these regimens.

Secondary

  • Compare the survival and failure-free survival of patients treated with these regimens.
  • Compare the toxicity profile of these regimens in these patients.
  • Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I*: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2.
  • Arm II*: Patients receive docetaxel, cisplatin, and pegfilgrastim as in arm I and dimesna IV over 30 minutes on day 1.

NOTE: *In both arms, darbepoetin alfa is administered SC on day 1 of each course for hemoglobin ≤ 11 g/dL.

In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Study Type

Interventional

Enrollment (Actual)

160

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
    • California
      • Mountain View, California, United States, 94040
        • El Camino Hospital
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
      • Wilmington, Delaware, United States, 19805
        • St. Francis Hospital
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Graham Hospital
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60640
        • Louis A. Weiss Memorial Hospital
      • Chicago, Illinois, United States, 60612-7243
        • University of Illinois Cancer Center
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago Westside Hospital
      • Eureka, Illinois, United States, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Clinic
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Hopedale, Illinois, United States, 61747
        • Hopedale Medical Complex
      • 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 - 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, P.C.
      • Peru, Illinois, United States, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, United States, 61362
        • St. Margaret's Hospital
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Hematology Oncology Associates of the Quad Cities
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Center at University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Veterans Affairs Medical Center - Baltimore
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Elkton MD, Maryland, United States, 21921
        • Union Hospital Cancer Center at Union Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Arch Medical Services, Incorporated at Center for Cancer Care Research
      • St. Louis, Missouri, United States, 63131
        • Missouri Baptist Cancer Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, United States, 68131-2197
        • Creighton University Medical Center
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center at Methodist Hospital - Omaha
    • 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 Hampshire
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology-Hematology, PA - Hooksett
      • Laconia, New Hampshire, United States, 03246
        • Lakes Region General Hospital
      • Manchester, New Hampshire, United States, 03103
        • Elliot Regional Cancer Center
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
    • New York
      • Glens Falls, New York, United States, 12801
        • Charles R. Wood Cancer Center at Glens Falls Hospital
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
      • Syracuse, New York, United States, 13215
        • Community General Hospital of Greater Syracuse
      • Syracuse, New York, United States, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Utica, New York, United States, 13502
        • Faxton Regional Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Kinston, North Carolina, United States, 28501
        • Lenoir Memorial Cancer Center
      • Wilmington, North Carolina, United States, 28401
        • Zimmer Cancer Center at New Hanover Regional Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Cancer Care Associates - Mercy Campus
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • McLeod Regional Medical Center
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, United States, 75216
        • Veterans Affairs Medical Center - Dallas
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Dallas, Texas, United States, 75235
        • Zale Lipshy University Hospital
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • St. Mary's Regional Cancer Center at St. Mary's Medical 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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed* non-small cell lung cancer of 1 of the following subtypes:

    • Squamous carcinoma
    • Basaloid carcinoma
    • Adenocarcinoma
    • Bronchoalveolar carcinoma
    • Adenosquamous carcinoma
    • Large cell carcinoma
    • Large cell neuroendocrine carcinoma
    • Giant cell carcinoma
    • Sarcomatoid carcinoma
    • Non-small cell carcinoma not otherwise specified NOTE: *Histologic or cytologic confirmation of recurrence is required for patients who have undergone prior complete resection
  • Stage IIIB disease due to malignant pleural effusion OR stage IV disease

  • Measurable disease

    • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

    • The following are considered nonmeasurable disease:

      • Bone lesions
      • Brain metastases or leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Abdominal masses not confirmed and followed by imaging techniques
      • Cystic lesions
      • Tumor lesions situated in a previously irradiated area
  • Brain metastases are allowed provided patient is neurologically stable and off steroids

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 mg/dL
  • AST ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ ULN

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No grade 2 or greater neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No other concurrent growth factors

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent hormonal therapy except steroids administered for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

  • See Disease Characteristics
  • Prior radiotherapy allowed for brain metastases only
  • No concurrent palliative radiotherapy

Surgery

  • See Disease Characteristics

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: Chemotherapy without BNP7787
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
Biological: darbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL
Biological: pegfilgrastim
6 mg sub Q day 2 of each cycle
Drug: cisplatin
75 mg/sq m IV over 1 hr Day 1 of each cycle
Drug: docetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
Experimental: Chemotherapy + BNP7787
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
Biological: darbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL
Biological: pegfilgrastim
6 mg sub Q day 2 of each cycle
Drug: cisplatin
75 mg/sq m IV over 1 hr Day 1 of each cycle
Drug: docetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
Drug: BNP7787
40 g IV over 30 min Day 1 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity
Time Frame: 12 weeks
Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Response
Time Frame: during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs
during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs
Survival
Time Frame: q 6 mon for 2 yrs after registration, then annually
q 6 mon for 2 yrs after registration, then annually

Collaborators and Investigators

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Antonius Miller, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

February 10, 2004

First Submitted That Met QC Criteria

February 11, 2004

First Posted (Estimate)

February 12, 2004

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-30303
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CDR0000350089 (Registry Identifier: NCI Physician Data Query)

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.

Clinical Trials on Anemia

Clinical Trials on darbepoetin alfa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe