Gemcitabine Plus Paclitaxel in Treating Patients With Advanced Non-small Cell Lung Cancer or Other Solid Tumor

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00004159
• Other study ID #: CDR0000067399
• Secondary ID: UAB-9720UAB-F970
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: December 10, 1999
• Last updated: November 18, 2013
• Start date: February 2000
• Est. completion date: February 2000

Study information

• Verified date: March 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Description:

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.

Recruitment information / eligibility

• 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• paclitaxel

Locations

Country	Name	City	State
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,