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A Phase 2 Trial of ALIMTA in Pretreated Patients With Unresectable or Metastatic Cancer of the Pancreas

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase 2 Trial of ALIMTA in Pretreated Patients With Unresectable or Metastatic Cancer of the Pancreas

Inclusion Criteria:

- Histological or cytological diagnosis of adenocarcinoma of the pancreas that is
locally advanced (Stage II, III) or metastatic (Stage IV), as staged by the American
Joint Committee on Cancer (AJCC; Protocol Attachment S041.2; Fleming et al. 1997),
and not amenable to resection with curative intent.

- Prior systemic first line chemotherapy with gemcitabine single agent or a combination
regimen including gemcitabine (not more than one prior systemic chemotherapy

- Uni-dimensionally measurable disease according to the RECIST criteria (Therasse et
al. 2000), defined as: At least one lesion that can be accurately measured in at
least one dimension, with the longest diameter greater than or equal to 2 cm with
conventional techniques or greater than or equal to 1.0 cm with spiral CT scans.
Ultrasound and X-ray are NOT allowed to measure or follow lesions.

Exclusion Criteria:

- Prior radiation of equal to or greater than 25% of the bone marrow (Cristy and
Eckerman 1987)

- Prior immunotherapy, biological therapy, and/or hormonal therapy for pancreas cancer.

- Prior systemic chemotherapy with 5-FU.

- Patient not yet recovered from the acute toxic effects of the treatment prior to
study enrollment.

- Radiotherapy within the last 4 weeks before study entry

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy.

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


Germany: Ethics Commission

Study ID:




Start Date:

October 2003

Completion Date:

April 2005

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms