- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00251407
Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies
August 7, 2012 updated by: Charles S. Fuchs, MD, Dana-Farber Cancer Institute
Phase I Study of Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: taxotere, cisplatin, irinotecan
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies.
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To define the dose-limiting toxicities of the combination of drugs.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charles S. Fuchs, MD, Dana-Farber Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1999
Primary Completion (Actual)
January 1, 2003
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
November 8, 2005
First Submitted That Met QC Criteria
November 8, 2005
First Posted (Estimate)
November 10, 2005
Study Record Updates
Last Update Posted (Estimate)
August 9, 2012
Last Update Submitted That Met QC Criteria
August 7, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99-149
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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