Combination Chemotherapy in Treating Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00009932
Recruitment Status : Unknown
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : June 6, 2003
Last Update Posted : May 15, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: cisplatin Drug: fenretinide Drug: paclitaxel Phase 1

Detailed Description:


  • 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 : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors
Study Start Date : January 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)



  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • Not specified


  • Platelet count at least 100,000/mm3
  • Absolute neutrophil count at least 1,500/mm3


  • 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)


  • Creatinine no greater than 1.5 mg/dL


  • No severe symptomatic cardiac disease


  • 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


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • No prior paclitaxel, cisplatin, or fenretinide
  • At least 4 weeks since other prior chemotherapy

Endocrine therapy:

  • Not specified


  • 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


  • At least 2 weeks since prior therapeutic surgery and recovered


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00009932

United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Gregory A. Otterson, MD Ohio State University Comprehensive Cancer Center Identifier: NCT00009932     History of Changes
Other Study ID Numbers: OSU-00H0186
CDR0000068425 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 6, 2003    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: October 2002

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action