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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00087087
First received: July 8, 2004
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: pemetrexed disodium
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 51
Study Start Date: July 2004
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087087

  Show 35 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Eli Lilly and Company
Investigators
Study Chair: David S. Miller, MD Simmons Cancer Center
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00087087     History of Changes
Other Study ID Numbers: GOG-0126Q, LILLY-H3E-US-JMGP, CDR0000372919
Study First Received: July 8, 2004
Last Updated: February 12, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014