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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Charles S. Fuchs, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00251407
First received: November 8, 2005
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Solid Tumor
 Drug: Taxotere
Drug: Cisplatin
Drug: CPT-11
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To assess the maximum tolerated dose of weekly taxotere, cisplatin and CPT-11 in patients with incurable solid tumor malignancies. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To define the dose-limiting toxicities of the combination of drugs. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: September 1999
Study Completion Date: April 2009
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251407

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Charles S. Fuchs, MD Dana-Farber Cancer Institute
  More Information

Publications:

Responsible Party: Charles S. Fuchs, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00251407     History of Changes
Other Study ID Numbers: 99-149
Study First Received: November 8, 2005
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Advanced solid tumor malignancy
cisplatin
CPT-11
taxotere

Additional relevant MeSH terms:
Neoplasms
Irinotecan
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013