We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00251407
First Posted: November 10, 2005
Last Update Posted: August 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Charles S. Fuchs, MD, Dana-Farber Cancer Institute
  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
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

Resource links provided by NLM:


Further study details as provided by Charles S. Fuchs, MD, 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 ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251407


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
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
First Submitted: November 8, 2005
First Posted: November 10, 2005
Last Update Posted: August 9, 2012
Last Verified: August 2012

Keywords provided by Charles S. Fuchs, MD, Dana-Farber Cancer Institute:
Advanced solid tumor malignancy
cisplatin
CPT-11
taxotere

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Irinotecan
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors