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

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00251407

Purpose

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.

Condition	Intervention	Phase
Solid Tumor	Drug: Taxotere Drug: Cisplatin Drug: CPT-11	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel Cisplatin Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title:	Phase I Study of Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To define the dose-limiting toxicities of the combination of drugs. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment:	46
Study Start Date:	September 1999
Estimated Study Completion Date:	January 2009
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251407

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Investigators

Principal Investigator:

Charles S. Fuchs, MD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Charles S. Fuchs, MD )
Study ID Numbers:	99-149
Study First Received:	November 8, 2005
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00251407
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Advanced solid tumor malignancy
cisplatin
CPT-11
taxotere

Study placed in the following topic categories:

Docetaxel
Cisplatin
Irinotecan

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009