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Biweekly Gemcitabine and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer and Solid Tumors: A Phase I/IIa Study


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Biweekly Gemcitabine and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer and Solid Tumors: A Phase I/IIa Study


OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of biweekly
administration of gemcitabine and paclitaxel in patients with advanced non-small cell lung
cancer (NSCLC) or other solid tumor. II. Determine the response rate, duration of response,
and disease free interval for this patient population after this therapy.

OUTLINE: This is a dose escalation study. Patients receive paclitaxel IV over 1 hour
followed 2 hours later by gemcitabine IV over 30 minutes on days 1, 15, and 29. Treatment
repeats every 6 weeks for a maximum of 8 courses. Cohorts of 3-5 patients receive escalating
doses of paclitaxel and gemcitabine until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose
limiting toxicity. Once the MTD is reached, an additional 14 patients (chemotherapy naive)
with advanced NSCLC are treated at the recommended phase II dose. Patients are followed
every 8 weeks for 6 months.

PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for the phase I portion and a
total of 14 patients will be accrued for the phase II portion of this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Francisco Robert, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000067399

NCT ID:

NCT00004159

Start Date:

February 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294