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Completed

NCT Number: NCT00109096

Study of Pemetrexed in the Treatment of Patients With Ovarian Cancer Who Have Failed Prior Platinum-Based Chemotherapy

The purposes of this study are to determine: - whether standard or higher doses of pemetrexed should be given to patients with ovarian or primary peritoneal cancer that has recurred; - the safety and side effects of standard and higher doses of pemetrexed given to patients with ovarian or primary peritoneal cancer that has recurred; - whether standard or higher doses of pemetrexed can help patients with ovarian or primary peritoneal cancer that has recurred.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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., Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must have been diagnosed with ovarian or primary peritoneal cancer
  • Patient must have had 1 or 2 prior platinum-based chemotherapeutic regimens.
  • Patient must have adequate health status.
  • Patient compliance and geographic proximity that allow for adequate follow up is required.
  • Signed informed consent from the patient or legal representative is required.

Exclusion criteria

  • Patient is pregnant or breast-feeding
  • Patient has received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Patient has previously participated in another study investigating pemetrexed.
  • Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, and corticosteroids.
  • Patient cannot be taking nonsteroidal anti-inflammatory drugs around the time of administration of study drug.

Treatment and study plan

Pemetrexed

Drug

Primary outcomes

  1. To assess the anti-tumor activity, as measured by tumor response rate (proportion of patients with complete or partial response, of 500 mg/m2 vs. 900 mg/m2 of pemetrexed therapy administered every 21 days

Secondary outcomes

  1. Time to response

  2. Duration of response

  3. Time to objective progressive disease (TtPD)

  4. Time to treatment failure (TtTF)

  5. Objective PFS

  6. OS

  7. To assess safety and toxicity profile of two doses of pemetrexed in patients with ovarian cancer

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Double-Blind Phase 2 Study of Two Doses of Pemetrexed in the Treatment of Platinum-Resistant, Epithelial Ovarian or Primary Peritoneal Cancer

Important dates

Study start
2005
Study completion
2007
First posted
Apr 25, 2005
Registry last updated
May 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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