Status:
COMPLETED
Gemcitabine and Carboplatin Followed By Docetaxel in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug m...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine and carboplatin followed by immediate vs delayed docetaxel. ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB with pleural effusion OR stage IV disease
- Recurrent disease after primary treatment with radiotherapy or surgery allowed
- Measurable disease or nonmeasurable disease
- Measurable disease, defined as at least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Nonmeasurable disease, defined as all other lesions, including small lesions (longest diameter less than 20 mm by conventional techniques OR less than 10 mm by spiral CT scan) or any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Cystic lesions
- Abdominal masses not confirmed and followed by imaging techniques
- No symptomatic CNS metastases
- Treated, stable CNS metastases allowed provided patient is not receiving radiotherapy or corticosteroids
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- ECOG 0-2
- Life expectancy
- At least 12 weeks
- Hematopoietic
- WBC at least 3,000/mm\^3
- Absolute neutrophil count at least 1,000/mm\^3
- Platelet count at least 100,000/mm\^3
- Hepatic
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 3.0 times upper limit of normal (ULN) (less than 5.0 times ULN for patients with documented benign disease)
- Alkaline phosphatase less than 3.0 times ULN (for patients with documented benign disease)
- Renal
- Creatinine no greater than 1.5 mg/dL
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after study participation
- No active and ongoing infection
- No concurrent serious systemic disorder that would preclude study participation
- No other primary malignancy within the past 5 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or T1 vocal cord cancer in remission
- Other prior cancers unlikely to affect survival for the next 3 years (e.g., low-grade early stage prostate cancer) are allowed
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent immunotherapy
- Chemotherapy
- No prior chemotherapy for NSCLC, including neoadjuvant and adjuvant therapy
- No other concurrent chemotherapy
- Endocrine therapy
- See Disease Characteristics
- No concurrent antitumor hormonal therapy (excluding contraceptives and replacement steroids)
- Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- Prior radiotherapy to less than 25% of bone marrow allowed provided the irradiated area is not the only site of measurable disease
- No concurrent radiotherapy
- Surgery
- See Disease Characteristics
- Other
- At least 3 weeks since prior therapy for cancer
- More than 4 weeks since prior investigational agents
- No other concurrent experimental medications
- No other concurrent therapy for cancer
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00074204
Start Date
October 1 2003
End Date
April 1 2008
Last Update
August 16 2010
Active Locations (1)
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1
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065