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Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
carboplatin
cisplatin
gemcitabine hydrochloride
paclitaxel
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung carcinoma of any of the following subtypes: Squamous cell Adenocarcinoma Large cell anaplastic Bronchioalveolar Non-small cell carcinoma not otherwise specified No small cell anaplastic elements allowed Must have: Recurrent disease after prior radiotherapy or surgery OR Stage IV disease with distant metastases OR Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest x-ray or pleural implants documented pathologically or on CT or chest x-ray Bidimensionally measurable or evaluable disease Brain metastases allowed provided clinically stable after treatment with surgery and/or radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled high blood pressure, unstable angina, or congestive heart failure No myocardial infarction within the past 6 months No serious ventricular arrhythmias requiring medication Other: Not pregnant or nursing Fertile patients must use effective contraception No other active malignancies requiring ongoing treatment No uncontrolled serious active infections No suspected hypersensitivity to agents that utilize Cremophor No evidence of neuropathy grade 2 or greater by history or physical examination PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for non-small cell lung cancer Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to only site of measurable or evaluable disease unless subsequent progression documented by physical exam, radiograph, or pathology Recovered from prior radiotherapy No concurrent radiotherapy except for whole brain radiation for developing brain metastases Surgery: See Disease Characteristics

Sites / Locations

  • Emory University Hospital - Atlanta
  • Iowa Methodist Medical Center
  • Mercy Medical Center
  • Iowa Lutheran Hospital
  • Alegent Health-Midlands Community Hospital
  • CCOP - Northern New Jersey
  • Cancer Institute of New Jersey
  • MBCCOP - University of New Mexico HSC
  • James P. Wilmot Cancer Center
  • CCOP - Oklahoma
  • Milton S. Hershey Medical Center
  • CCOP - Scott and White Hospital
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • Westmead Hospital
  • Instituto de Enfermedades Neoplasicas
  • San Juan City Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
June 13, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006004
Brief Title
Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
Official Title
A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2000 (Actual)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy 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 combination chemotherapy regimen is more effective for treating non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have non-small cell lung cancer.
Detailed Description
OBJECTIVES: Compare overall survival, response rate, and time to progression of patients with non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine and cisplatin. Compare the toxicities of each of these 2 regimens in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the past 6 months (less than 5% vs at least 5%) and disease stage (stage IIIB with pleural or pericardial effusion or pleural implants vs stage IV/recurrent). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1. Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 only. Treatment continues in both arms every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this study within 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung carcinoma of any of the following subtypes: Squamous cell Adenocarcinoma Large cell anaplastic Bronchioalveolar Non-small cell carcinoma not otherwise specified No small cell anaplastic elements allowed Must have: Recurrent disease after prior radiotherapy or surgery OR Stage IV disease with distant metastases OR Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest x-ray or pleural implants documented pathologically or on CT or chest x-ray Bidimensionally measurable or evaluable disease Brain metastases allowed provided clinically stable after treatment with surgery and/or radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled high blood pressure, unstable angina, or congestive heart failure No myocardial infarction within the past 6 months No serious ventricular arrhythmias requiring medication Other: Not pregnant or nursing Fertile patients must use effective contraception No other active malignancies requiring ongoing treatment No uncontrolled serious active infections No suspected hypersensitivity to agents that utilize Cremophor No evidence of neuropathy grade 2 or greater by history or physical examination PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for non-small cell lung cancer Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to only site of measurable or evaluable disease unless subsequent progression documented by physical exam, radiograph, or pathology Recovered from prior radiotherapy No concurrent radiotherapy except for whole brain radiation for developing brain metastases Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey J. Langer, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316-2301
Country
United States
Facility Name
Alegent Health-Midlands Community Hospital
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68128-4157
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
MBCCOP - University of New Mexico HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
CCOP - Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3453
Country
United States
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Instituto de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
San Juan City Hospital
City
San Juan
ZIP/Postal Code
00936-7344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
17264337
Citation
Langer C, Li S, Schiller J, Tester W, Rapoport BL, Johnson DH; Eastern Cooperative Oncology Group. Randomized phase II trial of paclitaxel plus carboplatin or gemcitabine plus cisplatin in Eastern Cooperative Oncology Group performance status 2 non-small-cell lung cancer patients: ECOG 1599. J Clin Oncol. 2007 Feb 1;25(4):418-23. doi: 10.1200/JCO.2005.04.9452.
Results Reference
result
Citation
Tester WJ, Stephenson P, Langer CJ, et al.: ECOG 1599: randomized phase II study of paclitaxel/carboplatin or gemcitabine/cisplatin in performance status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 22 (Suppl 14): A-7055, 630s, 2004.
Results Reference
result
Citation
Langer CJ, Stephenson P, Schiller J, et al.: ECOG 1599: randomized phase II study of paclitaxel/carboplatin vs cisplatin/gemcitabine in performance status (PS) 2 patients with treatment-naive advanced NSCLC. [Abstract] Lung Cancer 41 (Suppl 2): A-O52, S18, 2003.
Results Reference
result

Learn more about this trial

Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer

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