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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I Study of Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Taxotere
* Drug: Cisplatin
* Drug: CPT-11


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: taxotere, cisplatin, irinotecan<br> | Drug: Taxotere<br>* 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.<br>Drug: Cisplatin<br>* 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.<br>Drug: CPT-11<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the dose-limiting toxicities of the combination of drugs. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cisplatin, Advanced solid tumor malignancy, CPT-11, taxotere