Combination Chemotherapy in Treating Patients With Solid Tumors

NCT ID: NCT00009932

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

fenretinide

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Gregory A. Otterson, MD

Role: STUDY_CHAIR

Ohio State University Comprehensive Cancer Center

Locations

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

CDR0000068425

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2530

Identifier Type: -

Identifier Source: secondary_id

OSU-00H0186

Identifier Type: -

Identifier Source: org_study_id