Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

NCT00023907 | Terminated Phase 2

• 2 other identifiers: CDR0000068875GOG-0126N
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 44

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

Interventions

paclitaxel DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or persistent ovarian epithelial or primary peritoneal cancer * Measurable disease * At least 1 lesion measured in at least 1 dimension * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * At least 1 target lesion * Tumors within a previously irradiated field considered non-target lesions * Paclitaxel resistant * Treatment-free interval of less than 6 months duration after treatment with prior paclitaxel OR * Progression during prior paclitaxel-based therapy * Platinum resistant or refractory * Treatment-free interval of less than 6 months duration after treatment with prior platinum OR * Progression during prior platinum-based therapy * Ineligible for higher priority GOG protocol (any active GOG phase III protocol for the same patient population) PATIENT CHARACTERISTICS: Age: * Any age Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer * No grade 2 or greater neuropathy (sensory and motor) PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic or immunologic agents for cancer Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy for cancer and recovered * Received at least 1 but no more than 2 prior platinum-based chemotherapy regimens containing carboplatin, cisplatin, or other organoplatinum compound for primary or recurrent disease * Initial treatment may include high-dose therapy, consolidation, or extended therapy * Received at least 1 prior paclitaxel-based chemotherapy regimen * No prior paclitaxel or docetaxel with a schedule of less than a 3-week interval between doses * No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens Endocrine therapy: * At least 1 week since prior hormonal therapy for cancer * Concurrent hormone replacement therapy allowed Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy for cancer and recovered * No prior radiotherapy to site(s) of measurable disease * No prior radiotherapy to more than 25% of marrow-bearing areas Surgery: * At least 3 weeks since prior surgery for cancer and recovered Other: * At least 3 weeks since other prior therapy for cancer * No prior anticancer treatment that would preclude study * No concurrent amifostine or other protective reagents

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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (44)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

Women's Cancer Center at Community Hospital of Los Gatos

Los Gatos, California, 95032, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612-3824, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

Memorial Medical Center

Springfield, Illinois, 62794-9640, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Keesler Medical Center - Keesler Air Force Base

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1065, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0526, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001-3788, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

Southeast Gynecologic Oncology Associates

Knoxville, Tennessee, 37917, United States

Location

Genecologic Oncology Network

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-2516, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (1)

• Gynecologic Oncology Group; Markman M, Blessing J, Rubin SC, Connor J, Hanjani P, Waggoner S. Phase II trial of weekly paclitaxel (80 mg/m2) in platinum and paclitaxel-resistant ovarian and primary peritoneal cancers: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Jun;101(3):436-40. doi: 10.1016/j.ygyno.2005.10.036. Epub 2005 Dec 2.

  PMID: 16325893 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; 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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Maurie Markman, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: July 9, 2003
• Study Start: July 1, 2001
• Primary Completion: April 1, 2006
• Last Updated: April 11, 2013

Record last verified: 2004-05

Locations

US (44)