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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00251407

Collaborator

Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other)

Enrollment

Locations

Arm

115

Duration (Months)

15.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: Taxotere Drug: Cisplatin Drug: CPT-11	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 1999

Actual Primary Completion Date :

Jan 1, 2003

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: taxotere, cisplatin, irinotecan	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. Drug: 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. Drug: 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.

Arm

Intervention/Treatment

Experimental: taxotere, cisplatin, irinotecan

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.

Drug: 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.

Drug: 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.

Outcome Measures

Primary Outcome Measures

To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies. [3 years]

Secondary Outcome Measures

To define the dose-limiting toxicities of the combination of drugs. [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
3	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115