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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
paclitaxel
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
November 18, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004159
Brief Title
Gemcitabine Plus Paclitaxel in Treating Patients With Advanced Non-small Cell Lung Cancer or Other Solid Tumor
Official Title
Biweekly Gemcitabine and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer and Solid Tumors: A Phase I/IIa Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Study Start Date
February 2000 (undefined)
Primary Completion Date
February 2000 (Actual)
Study Completion Date
February 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Robert, MD, FACP
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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

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