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)

February 2, 2001
June 6, 2003
May 15, 2013
January 2001
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Complete list of historical versions of study NCT00009932 on Archive Site
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Combination Chemotherapy in Treating Patients With Solid Tumors
A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors

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.


  • 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.

Phase 1
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: cisplatin
  • Drug: fenretinide
  • Drug: paclitaxel
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000068425 ( Registry Identifier: PDQ (Physician Data Query) )
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Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Gregory A. Otterson, MD Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP