A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer

NCT00461786 | Completed Phase 2 Results DMC

• 2 other identifiers: 8364H3E-US-JMGP
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progression or unacceptable toxicity. This medication will be given over 10 minutes and may be administered intravenously (IV), through a vein in your arm. Vitamin supplementation is a required part of this study.

Conditions

Ovarian Cancer; Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor Response

  Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria.

  baseline to measured progressive disease (up to 44 months)

Secondary Outcomes (4)

• Number of Participants With Adverse Events by Grade

  every 21-day cycle up to 5 year follow-up

• Duration of Response

  time of initial response until documented tumor progression (up to 44 months)

• Progression-Free Survival

  baseline until documented tumor progression (up to 44 months)

• Overall Survival

  baseline until death from any cause up to 5-year follow-up

Study Arms (1)

Pemetrexed

EXPERIMENTAL

Drug: pemetrexed

Interventions

pemetrexed DRUG

900 mg/m2, intravenous (IV), every 21 days, until disease progression

Also known as: LY231514, Alimta

Pemetrexed

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed recurrent or persistent disease ovarian epithelial or primary peritoneal cancer
• Measurable disease
• Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease. Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel
• Treatment-free interval \< 6 months after prior platinum-based therapy OR progressed during platinum-based therapy
• Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol (i.e., any active phase III GOG protocol for the same patient population)

You may not qualify if:

• Patients who have had prior therapy with pemetrexed
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
• Patients who have received radiation to more than 25% of marrow

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Philadelphia, Pennsylvania, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: September 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: May 1, 2008
• Last Updated: December 4, 2009
• Results First Posted: August 24, 2009

Record last verified: 2009-12

Locations

US (1)