Combination Chemotherapy in Treating Patients With Solid Tumors

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: Determine the maximum tolerated dose, clinical toxicity, and recommended phase II dose of fenretinide when combined with paclitaxel and cisplatin in patients with refractory solid tumors.; Determine the pharmacokinetics of this regimen in these patients.; Determine the therapeutic response to this regimen in these patients. 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	Drug: cisplatin; Drug: fenretinide; Drug: paclitaxel
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: Histologically or cytologically proven refractory solid tumor for which paclitaxel and cisplatin are reasonable therapeutic options; No active CNS disease CNS metastasis allowed if measurable disease outside of the CNS and patient completed and recovered from 1 prior course of CNS radiotherapy (if clinically indicated) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR; Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3; Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL; ALT and AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if related to liver metastases) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No severe symptomatic cardiac disease Other: No clinically significant/evident retinopathy; No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ of the cervix; No uncontrolled infection; No other significant medical or psychiatric condition that would increase risk; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception for 1 month before, during, and for at least 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics; No prior paclitaxel, cisplatin, or fenretinide; At least 4 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy to only site of measurable/evaluable disease; No prior radiotherapy to more than 25% of bone marrow Surgery: At least 2 weeks since prior therapeutic surgery and recovered Other: At least 4 weeks since prior routine vitamin A of at least 10,000 IU/ day or beta carotene of at least 10 mg/day
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Study Chair: Gregory A. Otterson, MD Ohio State University Comprehensive Cancer Center
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