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Open-Label Single-Arm Phase II Study of ALIMTA in Combination With Oxaliplatin as First-Line Therapy in Advanced Gastric Carcinoma

Phase 2
18 Years
Not Enrolling
Advanced Gastric Carcinoma

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Trial Information

Open-Label Single-Arm Phase II Study of ALIMTA in Combination With Oxaliplatin as First-Line Therapy in Advanced Gastric Carcinoma

Inclusion Criteria

Inclusion Criteria

- Histologically proven diagnosis of adenocarcinoma of the stomach (including
adenocarcinoma of the gastroesophageal junction)

- Stage IIIB or Stage IV disease, according to American Joint Committee on Cancer
criteria, not amenable to curative surgery or radiation

- Disease status must be that of at least of one measurable disease as defined by
RECIST criteria.

- Performance Status of 2 on the ECOG Scale.

- Adequate organ function including the following:

- Bone marrow: absolute neutrophil count (ANC) >or equal to 1.5 * 109/L, platelets >or
equal to 100 *109/L, hemoglobin > or equal to 10 g/dL.

- Hepatic: bilirubin < or equal to 1.5 x ULN; alkaline phosphatase, aspartate
transaminase (AST) and alanine transaminase (ALT) < or equal to 3 x ULN (alkaline
phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor
involvement), serum albumin > or equal to3g/dL.

- Renal: Calculated creatinine clearance major or equal to 45 ml/min (using the
standard Cockcroft-Gault formula).

Exclusion Criteria

- No Prior palliative chemotherapy for advanced disease

- Previous radiation therapy is allowed but should have been limited and must not have
included whole pelvis radiation. Patients must have recovered from the toxic effects
of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy
must be completed at least 30 days before study enrollment

- Known or suspected brain metastasis

- Second primary malignancy (except for in situ carcinoma of the cervix or adequately
treated basal cell carcinoma of the skin or other malignancy treated at least 5 years
previously with no evidence of recurrence)

- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
2 days before, the day of, and 2 days after the dose of pemetrexed plus oxaliplatin

Type of Study:


Study Design:

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

Outcome Measure:

The primary objective of this study is to determine the response rate of Pemetrexed plus oxaliplatin as first-line therapy in patients with advanced gastric carcinoma.

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9 am-5 pm Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Chair

Investigator Affiliation:

Eli Lilly and Company


Italy: Ministry of Health

Study ID:




Start Date:

May 2004

Completion Date:

May 2006

Related Keywords:

  • Advanced Gastric Carcinoma
  • Carcinoma
  • Stomach Neoplasms