Lung Cancer Clinical Trial
Official title:
Biweekly Gemcitabine and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer and Solid Tumors: A Phase I/IIa Study
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 I/II trial to study the effectiveness of gemcitabine plus paclitaxel in
treating patients who have advanced non-small cell lung cancer or other solid tumor.
Status | Terminated |
Enrollment | 54 |
Est. completion date | February 2000 |
Est. primary completion date | February 2000 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Phase I portion (closed for accrual after the maximum tolerated
dose and dose limiting toxicity were determined) Histologically or cytologically confirmed
advanced non-small cell lung cancer (NSCLC) or other solid tumor for which no standard
curative treatment exists Phase II portion (open for accrual): Histologically proven stage
IV NSCLC without prior chemotherapy Measurable or evaluable disease No primary brain
tumors Brain metastases allowed if controlled by radiation or stereotactic radiosurgery No
lymphoproliferative disease No HIV related malignancies PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 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 Transaminases no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No serious nonmalignant disease No active/uncontrolled infection or bleeding (e.g., active peptic ulcer disease) No other primary malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No allergy to Cremophor PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Phase I: No prior paclitaxel or gemcitabine At least 3 weeks since other prior chemotherapy and recovered Phase II: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama Comprehensive Cancer Center | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | National Cancer Institute (NCI) |
United States,
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