Know Cancer

or
forgot password

A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gregory A. Otterson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

OSU-00H0186

NCT ID:

NCT00009932

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210