Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 trial to study the effectiveness of combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Camptothecin; Gemcitabine; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced solid tumor that is refractory to prior treatment

• Considered incurable with other modalities

• Measurable or evaluable disease

• The following are not considered measurable or evaluable:

• Bone metastases

• Pleural, pericardial, or peritoneal effusions

• Irradiated lesions (unless progression is documented after radiotherapy)

• Metastatic disease that has been followed using serum tumor markers allowed

• No symptomatic brain metastases

• Brain metastases may not be sole site of metastatic disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 12 weeks

Hematopoietic

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• AST and ALT no greater than 1.5 times normal

• Bilirubin no greater than 1.5 mg/dL

• No clinically apparent jaundice

Renal

• Creatinine no greater than 1.6 mg/dL OR

• Creatinine clearance at least 50 mL/min

Cardiovascular

• Cardiac function normal

• No uncontrolled heart disease

• No myocardial infarction within the past 3 months

• No congestive heart failure

• No unstable or uncontrolled angina

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No active infection requiring systemic therapy

• No uncontrolled seizures

• No uncontrolled diabetes mellitus

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior gemcitabine

• No prior camptothecin compounds

• Prior irinotecan allowed

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• At least 14 days since prior radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• More than 30 days since prior clinical trial participation

• No other concurrent investigational medications