Combination Chemotherapy in Treating Patients With Solid Tumors
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00009932 |
Recruitment Status
: Unknown
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted
: June 6, 2003
Last Update Posted
: May 15, 2013
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | February 2, 2001 | |||
First Posted Date ICMJE | June 6, 2003 | |||
Last Update Posted Date | May 15, 2013 | |||
Study Start Date ICMJE | January 2001 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00009932 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Combination Chemotherapy in Treating Patients With Solid Tumors | |||
Official Title ICMJE | A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors | |||
Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining fenretinide, paclitaxel, and cisplatin in treating patients who have solid tumors that have not responded to previous therapy. |
|||
Detailed Description | OBJECTIVES:
OUTLINE: This is a dose escalation, multicenter study of fenretinide. Patients receive oral fenretinide twice daily on days 1-7 and paclitaxel IV over 3 hours followed by cisplatin IV over 2 hours on day 2. On day 8 of course 1, patients also receive fenretinide once in the morning. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1 year. |
|||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE | Unspecified Adult Solid Tumor, Protocol Specific | |||
Intervention ICMJE |
|
|||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00009932 | |||
Other Study ID Numbers ICMJE | OSU-00H0186 CDR0000068425 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-2530 |
|||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Ohio State University Comprehensive Cancer Center | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
|
|||
PRS Account | National Cancer Institute (NCI) | |||
Verification Date | October 2002 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |