Amifostine in Treating Women With Ovarian, Peritoneal, Cervical, Fallopian Tube, Uterine, or Endometrial Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003624
• Other study ID #: CDR0000066705
• Secondary ID: GOG-9805
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: April 10, 2013
• Start date: December 1998

Study information

• Verified date: May 2006
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of amifostine in reducing the risk of side effects caused by cisplatin and paclitaxel in treating women who have ovarian, peritoneal, cervical, fallopian tube, uterine, or endometrial cancer.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neurotoxicity
• Neurotoxicity Syndromes
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer
• Sarcoma
• Uterine Cervical Neoplasms

Intervention

Drug:
• amifostine trihydrate

• cisplatin

• paclitaxel

Locations

Country	Name	City	State
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Moore DH, Donnelly J, McGuire WP, Almadrones L, Cella DF, Herzog TJ, Waggoner SE; Gynecologic Oncology Group. Limited access trial using amifostine for protection against cisplatin- and three-hour paclitaxel-induced neurotoxicity: a phase II study of the — View Citation