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

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID: NCT00251407
Run by: Dana-Farber Cancer Institute
People needed: 46
Starts: 1999-09-01
Expected to finish: 2009-04-01
Last updated by the study team: 2012-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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