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


Phase 2
N/A
N/A
Open (Enrolling)
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:

No

Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000372919

NCT ID:

NCT00087087

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Dayton Kettering, Ohio  45429
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Women's Cancer Center - Las Vegas Las Vegas, Nevada  89102
UMDNJ University Hospital Newark, New Jersey  07103
SUNY Downstate Medical Center Brooklyn, New York  11203
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Massey Cancer Center at Virginia Commonwealth University Richmond, Virginia  23298-0037
Hope A Women's Cancer Center Asheville, North Carolina  28801
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee Knoxville, Tennessee  37901
Williamette Gynecologic Oncology PC Portland, Oregon  97213