Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

NCT ID: NCT00004139

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2006-01-31

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.

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.

Detailed Description

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.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine + Irinotecan

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Gemcitabine + Docetaxel

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

Interventions

docetaxel

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caio Max S. Rocha Lima, MD

Role: STUDY_CHAIR

Medical University of South Carolina

Locations

Vincent T. Lombardi Cancer Research Center, Georgetown University

Washington D.C., District of Columbia, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

CCOP - Greenville

Greenville, South Carolina, United States

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, United States

Countries

United States

References

Rocha Lima CM, Rizvi NA, Zhang C, Herndon JE 2nd, Crawford J, Govindan R, King GW, Green MR; Cancer Leukemia Group B. Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. Ann Oncol. 2004 Mar;15(3):410-8. doi: 10.1093/annonc/mdh104.

Reference Type: RESULT

PMID: 14998842 (View on PubMed)

Rocha Lima CM, Rizvi NA, Zhang K, et al.: CALGB 39809: Randomized phase II trial of gemcitabine/irinotecan and gemcitabine/docetaxel in stage IIIB (malignant pleural effusion) or stage IV NSCLC. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1344, 2002.

Reference Type: RESULT

Other Identifiers

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CLB-39809

Identifier Type: -

Identifier Source: secondary_id

CDR0000067369

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-39809

Identifier Type: -

Identifier Source: org_study_id