Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find the highest dose of the combination of taxotere, cisplatin and CPT-11, that can be given without causing severe side effects. We also want to test the safety of this drug combination and see what effects (good and bad) it has on patients with advanced cancer for which there is no known curable treatment.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Cisplatin; Docetaxel; Irinotecan

Criteria

Inclusion Criteria:

• Histologically confirmed, incurable solid tumor malignancy

• 18 years of age or older

• ECOG performance status of < or = to 2

• Life expectancy of greater than 12 weeks

• WBC > 3,000/mm3

• ANC > 1,500/mm3

• Platelet count > 100,000/mm3

• Total bilirubin within normal limits

• SGOT < 2.5 x ULN

• Alkaline phosphatase < 4 x ULN

Exclusion Criteria:

• Prior chemotherapy for the treatment of metastatic or recurrent cancer

• Prior radiotherapy to greater than or equal to 15% of bone marrow

• Prior pelvic radiation therapy

• Prior nitrosoureas or mitomycin C

• Myocardial infarction in the past 6 months

• Major surgery in past 2 weeks

• Uncontrolled serious medical or psychiatric illness

• Uncontrolled diarrhea

• Peripheral neuropathy > grade 1

• Pregnant or lactating women

• Clinically apparent central nervous system metastases or carcinomatous meningitis