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. PURPOSE: Phase II trial to compare the effectiveness of gemcitabine plus either docetaxel or irinotecan in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
stage IV non-small cell lung cancer Squamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer Adenocarcinoma of the Lung large cell lung cancer	Drug: docetaxel  Drug: gemcitabine  Drug: irinotecan	Phase II

Further Study Details: 

OBJECTIVES: I. Compare the complete and overall response rate to gemcitabine and docetaxel versus gemcitabine and irinotecan in chemotherapy naive patients with stage IIIB or IV non-small cell lung cancer. II. Compare the overall and failure free survival, duration of response, and toxicity associated with these combination regimens in this patient population.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to disease stage (stage IIIB vs stage IV without CNS involvement vs stage IV with CNS involvement vs recurrent/progressive disease post surgery and/or radiotherapy). Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes immediately followed by irinotecan IV over 90 minutes on days 1 and 8. Arm II: Patients receive gemcitabine IV over 30 minutes immediately followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete response or stable disease receive treatment for least 6 courses and for 2 additional courses beyond the maximum response, and then at the investigator's discretion. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression or death.

PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study within 12 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed stage IIIB, IV, or recurrent non-small cell lung cancer (NSCLC) including: Squamous cell carcinoma; Adenocarcinoma (including bronchoalveolar cell); Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
• Stage IIIB eligible for other CALGB protocols consisting of combined chemotherapy and chest radiotherapy not permitted
• Malignant pleural effusion allowed
• CNS metastases allowed following completion of cranial radiotherapy
• Unidimesionally or bidimensionally measurable disease; Solid tumor mass or hilar lesion surrounded by aerated lung; Pleural based mass; Mediastinal or hilar adenopathy clearly measurable
• No bone only disease
• No pleural or pericardial effusions
• No irradiated lesions unless progression is documented following radiotherapy

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics; No prior chemotherapy for NSCLC
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; At least 2 weeks since prior radiotherapy; At least 2 weeks since prior whole brain radiotherapy or stereotactic radiotherapy for CNS disease
• Surgery: At least 2 weeks since prior surgery for CNS disease

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-1
• Life expectancy: Not specified
• Hematopoietic: Granulocyte 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 2 times upper limit of normal (ULN); Alkaline phosphatase less than 2.5 times ULN if SGOT is greater than 1.5 times ULN
• Renal: Creatinine no greater than 2.0 mg/dL
• Other: No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix or breast; Not pregnant or nursing; Fertile patients must use effective contraception

District of Columbia
      Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington,  District of Columbia,  20007,  United States
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Missouri
      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
Tennessee
      University of Tennessee, Memphis Cancer Center, Memphis,  Tennessee,  38163,  United States

Study chairs or principal investigators

Caio Max S. Rocha Lima,  Study Chair,  Cancer and Leukemia Group B   

Study ID Numbers:  CDR0000067369; CLB-39809
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004139
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08