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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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