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A Limited Access Trial Using Amifostine for Protection Against Cisplatin and 3-Hour Paclitaxel-Induced Neurotoxicity


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Neurotoxicity, Ovarian Cancer, Primary Peritoneal Cavity Cancer, Sarcoma

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Trial Information

A Limited Access Trial Using Amifostine for Protection Against Cisplatin and 3-Hour Paclitaxel-Induced Neurotoxicity


OBJECTIVES: I. Determine the efficacy of amifostine in reducing significant peripheral
neuropathy in women with ovarian, peritoneal, cervical, fallopian tube, uterine, or
endometrial cancer treated with cisplatin and paclitaxel. II. Determine the proportion of
patients on this regimen who experience significant peripheral neuropathy 3 months after
completing chemotherapy. III. Assess the overall toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours, amifostine IV over 10 minutes, and
cisplatin IV over 90 minutes. Treatment repeats every 3 weeks for 6 courses in the absence
of disease progression or unacceptable toxicity. Neurotoxicity is assessed and vibration
perception threshold testing is performed prior to each course of chemotherapy and at 3
months following the last treatment. Patients are followed every 3 months for 2 years, then
every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 29-59 patients will be accrued for this study within 18-36
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Ovarian, primary peritoneal, cervical, or fallopian tube
carcinoma, uterine sarcoma, or endometrial adenocarcinoma for which the proposed treatment
is cisplatin plus paclitaxel Must be ineligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper
limit of normal (ULN) AST and alkaline phosphatase no greater than 3 times ULN Renal:
Creatinine no greater than 2.0 mg/dL Cardiovascular: No hypertension for which medication
cannot be discontinued for 24 hours through the day of each chemotherapy treatment Other:
No history of neuropathy (e.g., diabetic neuropathy) No significant infection Prior
malignancy allowed if disease free for at least 12 months No physical disabilities
precluding vibration perception threshold testing of the upper and lower extremity (e.g.,
amputation, paraplegia)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for ovarian, primary peritoneal, or fallopian tube carcinoma, uterine
sarcoma, or endometrial adenocarcinoma Endocrine therapy: Not specified Radiotherapy: No
prior radiotherapy except for cervical carcinoma Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

David H. Moore, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066705

NCT ID:

NCT00003624

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Neurotoxicity
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Sarcoma
  • stage I cervical cancer
  • stage II cervical cancer
  • stage III cervical cancer
  • stage IV cervical cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • endometrial adenocarcinoma
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • stage I uterine sarcoma
  • stage II uterine sarcoma
  • stage III uterine sarcoma
  • stage IV uterine sarcoma
  • neurotoxicity
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma
  • Neurotoxicity Syndromes
  • Sarcoma

Name

Location
Chao Family Comprehensive Cancer Center Orange, California  92868
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Emory University Hospital - Atlanta Atlanta, Georgia  30322
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Washington University School of Medicine Saint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Cleveland Clinic Cancer Center Cleveland, Ohio  44195