Solid Tumor
Conditions
Keywords
Advanced solid tumor malignancy, cisplatin, CPT-11, taxotere
Brief 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.
Detailed 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.
Interventions
DRUGTaxotere
Given intravenously on days 1 and 8 of a 21-day cycle. Participants can continue to receive study drug as long as there disease does not worsen and they do not experience serious side effects.
DRUGCisplatin
Given intravenously on days 1 and 8 of a 21-day cycle. Participants can continue to receive study drug as long as there disease does not worsen and they do not experience serious side effects.
DRUGCPT-11
Given intravenously on days 1 and 8 of a 21-day cycle. Participants can continue to receive study drug as long as there disease does not worsen and they do not experience serious side effects.
Sponsors
Brigham and Women's Hospital
Massachusetts General Hospital
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| To define the dose-limiting toxicities of the combination of drugs. | 3 years |
Countries
United States
Outcome results
None listed