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

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 1

Conditions

Solid Tumor

Treatments

Drug: Taxotere

Drug: Cisplatin

Drug: CPT-11

Study type

Interventional

Funder types

Other

Identifiers

NCT00251407

99-149

Details and patient eligibility

About

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.

Full description

This is a Phase I clinical trial. We are unsure of the safest and most effective dose of the drugs and therefore are planning on treating 3-6 patients with a given dose before increasing to higher dose levels.
Each patient will receive approximately two cycles of therapy. On day one and day eight, they will receive taxotere, cisplatin and CPT-11 intravenously. The cycle will begin again on day 22.
The following tests and procedures will be performed: CAT scan prior to beginning therapy, after every 2 cycles of therapy, and at the end of the study; physical exam before each course of therapy; vital signs before and with each dose of therapy; routine blood tests before starting therapy and weekly during treatment; chest x-ray and echocardiogram before starting therapy and; toxicity assessment each week of therapy.
Patients will remain on the study as long as their cancer responds to treatment and they do not have unacceptable side effects.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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