Clinical trial NCT00461786: A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
Official title: A Phase II Evaluation of Pemetrexed (Alimta, LY231514l, IND # 40061) in the Treatment of Recurrent or Persistent Platinum Resistant Ovarian or Primary Peritoneal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Peritoneal Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Gynecologic Oncology Group
First posted: 2007-04-18
Enrollment: 51
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Tumor Response
timeFrame: baseline to measured progressive disease (up to 44 months)
Secondary outcomes:
measure: Number of Participants With Adverse Events by Grade
timeFrame: every 21-day cycle up to 5 year follow-up
measure: Duration of Response
timeFrame: time of initial response until documented tumor progression (up to 44 months)
measure: Progression-Free Survival
timeFrame: baseline until documented tumor progression (up to 44 months)
measure: Overall Survival
timeFrame: baseline until death from any cause up to 5-year follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: 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
state: Pennsylvania
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: