Combination Chemotherapy in Treating Patients With Solid Tumors

NCT00009932 | Unknown Phase 1

• 3 other identifiers: OSU-00H0186CDR0000068425NCI-2530
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

cisplatin DRUG

fenretinide DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Interventions

Cisplatin; Fenretinide; Paclitaxel

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Taxoids; Cyclodecanes; Diterpenes

Study Officials

• Gregory A. Otterson, MD

  Ohio State University Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: June 6, 2003
• Study Start: January 1, 2001
• Last Updated: May 15, 2013

Record last verified: 2002-10

Locations

US (1)