Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies
Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Solid Tumor
Intervention: Taxotere (Drug); Cisplatin (Drug); CPT-11 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s): Charles S. Fuchs, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
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.
Clinical Details
Official title: Phase I Study of Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies.
Secondary outcome: To define the dose-limiting toxicities of the combination of drugs.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: September 1999
Last updated: August 7, 2012
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