Status:
COMPLETED
Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 th...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00251407
Start Date
September 1 1999
End Date
April 1 2009
Last Update
August 9 2012
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115