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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251407
• Other study ID #: 99-149
• Status: Completed
• Phase: Phase 1
• First received: November 8, 2005
• Last updated: August 7, 2012
• Start date: September 1999
• Est. completion date: April 2009

Study information

• Verified date: August 2012
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2009
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 wit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies.		3 years	No
Secondary	To define the dose-limiting toxicities of the combination of drugs.		3 years	Yes