NCT00251407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

3.3 years

First QC Date

November 8, 2005

Last Update Submit

August 7, 2012

Conditions

Solid Tumor

Keywords

Advanced solid tumor malignancycisplatinCPT-11taxotere

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (1)

  • To define the dose-limiting toxicities of the combination of drugs.

    3 years

Study Arms (1)

taxotere, cisplatin, irinotecan

EXPERIMENTAL
Drug: TaxotereDrug: CisplatinDrug: CPT-11

Interventions

TaxotereDRUG

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.

taxotere, cisplatin, irinotecan
CisplatinDRUG

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.

taxotere, cisplatin, irinotecan
CPT-11DRUG

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.

taxotere, cisplatin, irinotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed, incurable solid tumor malignancy
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related 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 with metastatic esophagogastric cancer. Ann Oncol. 2009 Mar;20(3):475-80. doi: 10.1093/annonc/mdn658. Epub 2009 Jan 12.

    PMID: 19139178RESULT

MeSH Terms

Interventions

DocetaxelCisplatinIrinotecan

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Charles S. Fuchs, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 10, 2005

Study Start

September 1, 1999

Primary Completion

January 1, 2003

Study Completion

April 1, 2009

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations

US(3)