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A Phase I Trial of Fenretinide in Combination With Paclitaxel and Cisplatin


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial of Fenretinide in Combination With Paclitaxel and Cisplatin


OBJECTIVES:

- Determine the maximum tolerated dose of the combination of fenretinide, paclitaxel, and
cisplatin in patients with advanced solid tumors.

- Determine the effect of fenretinide on the pharmacokinetics of paclitaxel and
cisplatin.

- Assess the relationship between dose or plasma levels of fenretinide and the safety and
antitumor effects, in terms of overall response, response rate, and progression-free
survival rate, in these patients.

OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin.

Patients receive oral fenretinide twice daily for 7 days. Patients receive paclitaxel IV
over 3 hours and cisplatin IV over 30 minutes on day 7. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin 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. Once the MTD is
determined, additional patients are accrued to receive paclitaxel and cisplatin at the
recommended phase II dose.

PROJECTED ACCRUAL: Approximately 15-24 patients will be accrued for this study within 12-24
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed advanced solid tumor not amenable to
conventional surgery, radiotherapy, or chemotherapy

- No brain metastases or primary brain tumors

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- At least 12 weeks

Hematopoietic:

- WBC at least 3,500/mm^3

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin greater than 9.0 g/dL

Hepatic:

- Bilirubin less than 1.6 mg/dL

- AST and ALT less than 2 times upper limit of normal

- PT and PTT normal OR

- INR less than 1.1

Renal:

- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- No New York Heart Association class III or IV heart disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No extensive signs of macular degeneration, including exudative or atrophic macular
lesions reducing corrected vision to less than 20/40

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and
recovered

- Prior platinum-containing agents and taxane exposure allowed with no evidence of
neurotoxicity

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- No concurrent vitamin A supplements

- No concurrent supplemental antioxidants

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined.

Outcome Time Frame:

Courses (7 days) repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Safety Issue:

Yes

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU3Y99

NCT ID:

NCT00005819

Start Date:

April 2000

Completion Date:

August 2006

Related Keywords:

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

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065