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Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Sponsor
Fox Chase Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00054392
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
57
Locations
0
Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

OBJECTIVES:

  • Compare the overall survival of patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with gemcitabine and carboplatin vs gemcitabine and paclitaxel vs paclitaxel and carboplatin.

  • Compare the overall response rate and time to progression in patients treated with these regimens.

  • Compare the toxic effects of these regimens in these patients.

  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss within the past 6 months (less than 5% vs at least 5%), disease stage (IIIB vs IV), and brain metastases (present vs absent). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1.

  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1.

  • Arm III: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1.

In all arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 6 weeks during study treatment, and then every 3 months until progressive disease is documented.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 1,134 patients (378 per treatment arm) will be accrued for this study within 2 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
A Randomized, Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic (Stage IIIB, IV) Non-Small Cell Lung Cancer
Study Start Date :
Sep 1, 2001
Actual Primary Completion Date :
Sep 1, 2001
Actual Study Completion Date :
Sep 1, 2001

Outcome Measures

Primary Outcome Measures

  1. Survival []

Secondary Outcome Measures

  1. Tumor response rate []

  2. Time to disease progression []

  3. Quality of life as measured by the Functional Assessment of Cancer -Lung (FACT-L) questionnaire at baseline, every 6 weeks during study treatment, and then every 3 months thereafter []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following types:

  • Squamous cell

  • Adenocarcinoma

  • Large cell anaplastic

  • Bronchoalveolar

  • Non-small cell carcinoma not otherwise specified NOTE: Mixed tumors are categorized by the predominant cell type (tumors with small-cell anaplastic elements are ineligible)

  • Evidence of at least 1 of the following:

  • Clinically documented recurrent disease after prior radiation or surgery

  • Stage IV disease (distant metastases)

  • Stage IIIB disease presenting with 1 of the following:

  • Pleural or pericardial effusion by CT scan or chest x-ray

  • Pleural implants documented pathologically or seen on CT scan or x-ray

  • Measurable or evaluable disease

  • No brain metastases unless clinically stable after surgery and/or radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3

  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL

  • AST less than 5 times upper limit of normal

Renal

  • Creatinine no greater than 1.5 mg/dL OR

  • Creatinine clearance at least 40 mL/min

Other

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception

  • No hypersensitivity to agents that contain Cremophor EL (polyoxyethylated castor oil)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for advanced NSCLC

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

  • Recovered from prior radiotherapy

  • No prior radiotherapy to the only site of measurable disease, unless the site had subsequent progression of disease documented by physical exam, radiography, or pathology

  • No concurrent radiotherapy (except for brain metastases)

Surgery

  • See Disease Characteristics

Other

  • No concurrent aminoglycoside antibiotics

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda California United States 92354
2 New Hope Cancer and Research Institute - Pomona Pomona California United States 91767
3 Lawrence and Memorial Hospital New London Connecticut United States 06320
4 University of Florida Shands Cancer Center Gainesville Florida United States 32610-0383
5 Lakeland Regional Cancer Center at Lakeland Regional Medical Center Lakeland Florida United States 33805
6 Gulf Coast Cancer Treatment Center Panama City Florida United States 32405-4587
7 Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia United States 30033
8 Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey Illinois United States 60426
9 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
10 Cancer Center of Indiana New Albany Indiana United States 47150
11 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
12 Annapolis Oncology Center Annapolis Maryland United States 21401
13 Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland United States 21201
14 Greater Baltimore Medical Center Cancer Center Baltimore Maryland United States 21204
15 Baystate Regional Cancer Program at D'Amour Center for Cancer Care Springfield Massachusetts United States 01107
16 Fallon Clinic at Worcester Medical Center Worcester Massachusetts United States 01608
17 West Michigan Cancer Center Kalamazoo Michigan United States 49007-3731
18 Sletten Regional Cancer Institute at Benefis Healthcare Great Falls Montana United States 59405
19 Hunterdon Regional Cancer Center at Hunterdon Medical Center Flemington New Jersey United States 08822
20 Howell New Jersey United States 07731
21 Jersey Shore Cancer Center at Jersey Shore University Medical Center Neptune New Jersey United States 07754
22 AtlantiCare Regional Medical Center Pomona New Jersey United States 08240
23 Mercer Bucks Oncology-Hematology Trenton New Jersey United States 08618
24 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
25 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina United States 27599-7295
26 Cape Fear Valley Medical Center Fayetteville North Carolina United States 28302-2000
27 Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina United States 27834
28 Aultman Hospital Cancer Center at Aultman Health Foundation Canton Ohio United States 44710-1799
29 Cleveland Clinic Cancer Center at Fairview Hospital Cleveland Ohio United States 44111
30 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
31 Parma Community General Hospital Parma Ohio United States 44129
32 Rosenfeld Cancer Center at Abington Memorial Hospital Abington Pennsylvania United States 19001
33 Falling Spring Medical Associates Chambersburg Pennsylvania United States 17201
34 Hematology-Oncology Associates of Northeastern Pennsylvania Dunmore Pennsylvania United States 18512
35 PinnacleHealth Regional Cancer Center at Polyclinic Hospital Harrisburg Pennsylvania United States 17110
36 Richard G. Laube Cancer Center at ACMH Kittanning Pennsylvania United States 16201
37 Lancaster Cancer Center Lancaster Pennsylvania United States 17605-0396
38 Central Pennsylvania Hematology and Medical Oncology Associates, PC Lemoyne Pennsylvania United States 17043
39 Paoli Hematology-Oncology PC at Paoli Memorial Hospital Paoli Pennsylvania United States 19301
40 Hahnemann University Hospital Philadelphia Pennsylvania United States 19102-1192
41 Drexel University College of Medicine - Center City Hahnemann Campus Philadelphia Pennsylvania United States 19102
42 Fox Chase Cancer Center CCOP Research Base Philadelphia Pennsylvania United States 19104-4283
43 Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia Philadelphia Pennsylvania United States 19106
44 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
45 Allegheny Cancer Center at Allegheny General Hospital Pittsburgh Pennsylvania United States 15212-4772
46 Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15232
47 Pottstown Memorial Regional Cancer Center Pottstown Pennsylvania United States 19464
48 St. Joseph Medical Center Reading Pennsylvania United States 19603
49 Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania United States 19096
50 South Carolina Oncology Associates, PA Columbia South Carolina United States 29210
51 Coastal Cancer Center - Myrtle Beach Myrtle Beach South Carolina United States 29572
52 Family Cancer Center, PLLC - Collierville Collierville Tennessee United States 38077
53 Baptist Regional Cancer Center at Baptist Hospital of East Tennessee Knoxville Tennessee United States 37901
54 University of Virginia Cancer Center at UV Health System Charlottesville Virginia United States 22908
55 David Lee Outpatient Cancer Center at Charleston Area Medical Center Charleston West Virginia United States 25304-1297
56 Morgantown Internal Medicine Group, Incorporated Morgantown West Virginia United States 26505
57 Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown West Virginia United States 26506-9162

Sponsors and Collaborators

  • Fox Chase Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Joseph A. Treat, MD, Fox Chase Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00054392
Other Study ID Numbers:
  • ALPHA-A1-99002L
  • CDR0000270434
First Posted:
Feb 6, 2003
Last Update Posted:
Jul 11, 2013
Last Verified:
Jul 1, 2013
Keywords provided by , ,
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
large cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Gemcitabine
Paclitaxel
Carboplatin

Study Results

No Results Posted as of Jul 11, 2013