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Phase 1/2 Study of Pemetrexed Plus Cisplatin in Unresectable, Advanced Gastric Carcinoma.


Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Both
Neoplasm, Gastric

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Trial Information

Phase 1/2 Study of Pemetrexed Plus Cisplatin in Unresectable, Advanced Gastric Carcinoma.


Inclusion Criteria:



- Histological proven diagnosis of adenocarcinoma of the stomach

- Stage IV disease not amenable to curative surgery.

- Disease status must be that of measurable disease as defined by Response Evaluation
Criteria In Solid Tumors (RECIST) criteria.

- Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale.

- Adequate organ functions

Exclusion Criteria:

- Prior palliative chemotherapy for advanced gastric cancer.

- Pregnancy and breast feeding.

- Known or suspected brain metastasis and secondary primary malignancy

- Inability to interrupt aspirin, or other non-steroidal anti-inflammatory agents for a
5-day period.

- Inability or unwillingness to take folic acid or vitamin B12 supplementation.

- Concurrent administration of any other tumor therapy.

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:

Objective Best Tumor Response

Outcome Time Frame:

baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559, Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Taiwan: Department of Health

Study ID:

7461

NCT ID:

NCT00320515

Start Date:

March 2004

Completion Date:

July 2008

Related Keywords:

  • Neoplasm, Gastric
  • Neoplasms
  • Stomach Neoplasms

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