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A Phase 1 and 2 Clinical Trial of ALIMTA® (Pemetrexed) in Combination With Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cancer

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Trial Information

A Phase 1 and 2 Clinical Trial of ALIMTA® (Pemetrexed) in Combination With Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer


Inclusion Criteria:



- Diagnosis of ovarian or primary peritoneal cancer confirmed by pathology

- Patients must have recurrent ovarian cancer which is sensitive to platinum therapy

- Prior radiation therapy is allowed

Measurable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST)
guidelines, or non-measurable but cancer antigen 125 (CA-125) greater than or equal to 2X
upper limit.

Exclusion Criteria:

- More than 2 lines of therapy for ovarian or primary peritoneal cancer.

- Pregnant or breast feeding.

- Have 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.

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:

Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin

Outcome Description:

MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 and carboplatin Area Under the Concentration-Time Curve (AUC) up to 6 mg/mL*min based on observed pattern of dose limiting toxicity (DLT). See Outcome #3 for DLT. If none of 3 initial participants at a given level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. If at least 2 participants experienced a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from a different Phase 2 Study (NCT00109096), further dose escalations were not explored.

Outcome Time Frame:

First treatment to toxicity (up to 18 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:

9516

NCT ID:

NCT00489359

Start Date:

July 2005

Completion Date:

February 2010

Related Keywords:

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

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