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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
Open (Enrolling)
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


- 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

Inclusion Criteria


- 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)



- Any age

Performance status

- GOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL


- 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


- Creatinine clearance ≥ 45 mL/min


- 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


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


- 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


- See Disease Characteristics

- No prior radiotherapy to > 25% of bone marrow

- At least 2 weeks since prior radiotherapy and recovered


- Recovered from prior surgery


- 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:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:


Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Federal Government

Study ID:




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



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