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

NCT00006004 | Completed Phase 2

• 2 other identifiers: CDR0000068012E-1599
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 16

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.

Conditions

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

Interventions

carboplatin DRUG

cisplatin DRUG

gemcitabine hydrochloride DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Mercy Medical Center

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316-2301, United States

Location

Alegent Health-Midlands Community Hospital

Papillion, Nebraska, 68128-4157, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Instituto de Enfermedades Neoplasicas

Lima, 34, Peru

Location

San Juan City Hospital

San Juan, 00936-7344, Puerto Rico

Location

Related Publications (3)

• 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.

  PMID: 17264337 RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Carboplatin; Cisplatin; Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Corey J. Langer, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: August 22, 2000
• Primary Completion: January 1, 2005
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

PR (1); US (13); PE (1); AU (1)