Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor M... | NCT00251407

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

NCT00251407

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Aug 9, 2012Estimated

Enrollment

46Actual

Phase

Phase 1

Conditions

Solid Tumor

Interventions

Taxotere
Cisplatin
CPT-11

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1999

Primary Completion Date

Jan 2003Actual

Completion Date

Apr 2009Actual

First Submitted Date

Nov 8, 2005

First Submission Date that Met QC Criteria

Nov 8, 2005

First Posted Date

Nov 10, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2012

Last Update Posted Date

Aug 9, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Charles S. Fuchs, MD, Principal Investigator, Dana-Farber Cancer InstitutePrincipal Investigator

Lead Sponsor

Dana-Farber Cancer InstituteOTHER

Collaborators

Name	Class
Brigham and Women's Hospital	OTHER
Massachusetts General Hospital	OTHER

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
taxotere, cisplatin, irinotecan	Experimental		Drug: Taxotere Drug: Cisplatin Drug: CPT-11

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Taxotere	Drug	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles S. Fuchs, MD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Brigham and Women's Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19139178	Result	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.

ID	Term
D000077143	Docetaxel
D002945	Cisplatin
D000077146	Irinotecan

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic