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Phase II Randomized Trial of Gemcitabine/Docetaxel and Gemcitabine/Irinotecan in Stage IIIB/IV Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Phase II Randomized Trial of Gemcitabine/Docetaxel and Gemcitabine/Irinotecan in Stage IIIB/IV Non-Small Cell Lung Cancer

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

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.

Inclusion 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
Unidimensionally 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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Caio Max S. Rocha Lima, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina


United States: Federal Government

Study ID:




Start Date:

September 1999

Completion Date:

January 2006

Related Keywords:

  • Lung Cancer
  • 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
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
Barnes-Jewish Hospital Saint Louis, Missouri  63110
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
CCOP - Greenville Greenville, South Carolina  29615