Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies
NCT ID: NCT00251407
Last Updated: 2012-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
1999-09-30
2009-04-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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taxotere, cisplatin, irinotecan
Taxotere
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.
Cisplatin
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.
CPT-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.
Interventions
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Taxotere
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.
Cisplatin
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.
CPT-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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Charles S. Fuchs, MD
Principal Investigator
Principal Investigators
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Charles S. Fuchs, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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Enzinger PC, Ryan DP, Clark JW, Muzikansky A, Earle CC, Kulke MH, Meyerhardt JA, Blaszkowsky LS, Zhu AX, Fidias P, Vincitore MM, Mayer RJ, Fuchs CS. Weekly docetaxel, cisplatin, and irinotecan (TPC): results of a multicenter phase II trial in patients with metastatic esophagogastric cancer. Ann Oncol. 2009 Mar;20(3):475-80. doi: 10.1093/annonc/mdn658. Epub 2009 Jan 12.
Other Identifiers
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99-149
Identifier Type: -
Identifier Source: org_study_id