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

August 7, 2012 updated by: Charles S. Fuchs, MD, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: taxotere, cisplatin, irinotecan
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To define the dose-limiting toxicities of the combination of drugs.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charles S. Fuchs, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (Actual)

January 1, 2003

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

November 8, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 10, 2005

Study Record Updates

Last Update Posted (Estimate)

August 9, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solid Tumor

Clinical Trials on Taxotere

Subscribe