Pemetrexed Disodium in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Ovarian Cancer Clinical Trial

Official title:

A Phase II Evaluation Of Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087087
• Other study ID #: GOG-0126Q
• Secondary ID: LILLY-H3E-US-JMG
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2004
• Last updated: February 12, 2014
• Start date: July 2004

Study information

• Verified date: February 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: National Cancer Institute
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

Description:

OBJECTIVES:

• Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols.

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

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.

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

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial or primary peritoneal cancer

• Recurrent or persistent disease

• Measurable disease

• At least 1 unidimensionally measurable target lesion = 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR = 10 mm by spiral CT scan

• Tumors within a previously irradiated field are considered non-target lesions

• Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease

• Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment

• Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel

• Platinum-resistant or refractory disease

• Treatment-free interval < 6 months after prior platinum-based therapy OR progressed during platinum-based therapy

• Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

• Hemoglobin = 9 g/dL

Hepatic

• Bilirubin = 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase = 3 times ULN*

• AST and ALT = 3 times ULN* NOTE: * = 5 times ULN if due to hepatic metastases

Renal

• Creatinine clearance = 45 mL/min

Other

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• No neuropathy (sensory or motor) > grade 1

• No active infection requiring antibiotics

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 3 months after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• One prior noncytotoxic (biologic or cytostatic) regimen allowed for management of recurrent or refractory disease, including, but not limited to, the following:

• Monoclonal antibodies

• Cytokines

• Small-molecule inhibitors of signal transduction

• At least 3 weeks since prior biologic or immunologic therapy

• At least 24 hours since prior growth factors

• No concurrent routine colony-stimulating factors

Chemotherapy

• See Disease Characteristics

• Recovered from prior chemotherapy

• No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens

• No prior pemetrexed disodium

Endocrine therapy

• At least 1 week since prior hormonal therapy for the malignant tumor

• Concurrent hormone replacement therapy allowed

Radiotherapy

• See Disease Characteristics

• No prior radiotherapy to > 25% of bone marrow

• At least 2 weeks since prior radiotherapy and recovered

Surgery

• Recovered from prior surgery

Other

• No prior cancer treatment that would preclude study participation

• No non-steroidal anti-inflammatory drugs (NSAIDs) for 2-5 days before, during, and for 1-2 days after study drug administration

• Concurrent low-dose (= 325 mg/day) aspirin allowed

• At least 3 weeks since other prior therapy for the malignant tumor

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• pemetrexed disodium

Locations

Country	Name	City	State
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	Hope A Women's Cancer Center	Asheville	North Carolina
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	CCOP - Dayton	Dayton	Ohio
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Baptist Regional Cancer Center at Baptist Hospital of East Tennessee	Knoxville	Tennessee
United States	Women's Cancer Center - Las Vegas	Las Vegas	Nevada
United States	UMDNJ University Hospital	Newark	New Jersey
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia
United States	Williamette Gynecologic Oncology PC	Salem	Oregon
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Stony Brook University Cancer Center	Stony Brook	New York
United States	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	Eli Lilly and Company, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor activity			No
Primary	Toxicity			Yes