Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors

NCT00078845 | Completed Phase 2

• 4 other identifiers: CDR0000330006MDA-CCC-0223MDA-CCC-0203MDA-2003-0789
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 15

Brief Summary

RATIONALE: Amifostine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy. PURPOSE: This phase II trial is studying how well amifostine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received paclitaxel for solid tumors.

Conditions

Breast Cancer; Lung Cancer; Neurotoxicity; Ovarian Cancer; Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

neurotoxicity; unspecified adult solid tumor, protocol specific; recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer; recurrent non-small cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; limited stage small cell lung cancer; extensive stage small cell lung cancer; recurrent small cell lung cancer; recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; recurrent ovarian epithelial cancer; stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

• Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale

  11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.

  12 weeks

Study Arms (1)

Amifostine

EXPERIMENTAL

500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.

Drug: Amifostine

Interventions

Amifostine DRUG

500 mg three times a week.

Also known as: amifostine trihydrate

Amifostine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of a solid tumor, including, but not limited to the following: * Ovarian cancer * Lung cancer * Prostate cancer * Breast cancer * Previously treated with paclitaxel * Peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities) believed to be caused by paclitaxel only or the combination of paclitaxel and carboplatin * At least 18 out of 44 on the FACT-GOG-NTX scale * Persistent neuropathy for at least 2, but no more than 12 months after chemotherapy * Not improving * No other possible cause of neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * Karnofsky 50-100% Life expectancy * More than 2 months Hematopoietic * Not specified Hepatic * Bilirubin ≤ 2.0 mg/dL Renal * Creatinine ≤ 2.0 mg/dL * Calcium ≥ lower limit of normal Cardiovascular * See Disease Characteristics * No prior cerebrovascular accident Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other significant comorbid medical condition that would preclude study participation * No known sensitivity to aminothiol compounds PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior cisplatin * No chemotherapy during and for at least 3 months after study participation Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No concurrent monoamine oxidase inhibitors

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Christus St. Frances Cabrini Center for Cancer Care

Alexandria, Louisiana, 71301, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

University of Texas M.D. Anderson CCOP Research Base

Houston, Texas, 77030-4009, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

All Saints Cancer Center at Wheaton Franciscan Healthcare

Racine, Wisconsin, 53405, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Neurotoxicity Syndromes; Ovarian Neoplasms; Prostatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Carcinoma, Ovarian Epithelial

Interventions

Amifostine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Arthur Forman, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 9, 2004
• Study Start: May 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: October 17, 2012

Record last verified: 2012-10

Locations

US (15)