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Phase I Study of Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies

Phase 1
18 Years
Not Enrolling
Solid Tumor

Thank you

Trial Information

Phase I Study of Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies

- 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

- Patients will remain on the study as long as their cancer responds to treatment and
they do not have unacceptable side effects.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Charles S. Fuchs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 1999

Completion Date:

April 2009

Related Keywords:

  • Solid Tumor
  • Advanced solid tumor malignancy
  • cisplatin
  • CPT-11
  • taxotere
  • Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617