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A Phase II Evaluation of Pemetrexed (Alimta, LY231514l, IND # 40061) in the Treatment of Recurrent or Persistent Platinum Resistant Ovarian or Primary Peritoneal Carcinoma


Phase 2
N/A
N/A
Not Enrolling
Female
Ovarian Cancer, Peritoneal Cancer

Thank you

Trial Information

A Phase II Evaluation of Pemetrexed (Alimta, LY231514l, IND # 40061) in the Treatment of Recurrent or Persistent Platinum Resistant Ovarian or Primary Peritoneal Carcinoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response

Outcome Time Frame:

baseline to measured progressive disease (up to 44 months)

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

8364

NCT ID:

NCT00461786

Start Date:

September 2004

Completion Date:

May 2008

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

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 Philadelphia, Pennsylvania