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

2014-08-27 03:58:38 | BioPortfolio

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.

Study Design

Primary Purpose: Supportive Care

Conditions

Cervical Cancer

Intervention

amifostine trihydrate, cisplatin, paclitaxel

Location

Chao Family Comprehensive Cancer Center
Orange
California
United States
92868

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:38-0400

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Medical and Biotech [MESH] Definitions

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.

A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.

A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.

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