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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00023907
• Other study ID #: CDR0000068875
• Secondary ID: GOG-0126N
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2001
• Last updated: April 10, 2013
• Start date: July 2001

Study information

• Verified date: May 2004
• 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.

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.

Description:

OBJECTIVES:

• Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer.

• Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• paclitaxel

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	CCOP - Evanston	Evanston	Illinois
United States	University of Texas Medical Branch	Galveston	Texas
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Keesler Medical Center - Keesler Air Force Base	Keesler AFB	Mississippi
United States	Southeast Gynecologic Oncology Associates	Knoxville	Tennessee
United States	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Women's Cancer Center at Community Hospital of Los Gatos	Los Gatos	California
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Genecologic Oncology Network	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center	Orange	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Memorial Medical Center	Springfield	Illinois
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & 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. G — View Citation