Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

Phase 2CompletedNCT00320515

Eli Lilly and Company89 enrolled

Overview

This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin for patients with unresectable, advanced gastric cancer who had no prior palliative chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase 2, which has been completed and now a total of 60 qualified patients will be enrolled in the phase 2 of this study. The treating physician will determined the maximum number of cycles of pemetrexed plus cisplatin that a patient may receive in this study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasm, Gastric

Interventions

pemetrexedDRUG

Phase 1 - dose escalating: 600 mg/m2 level 1, 700 mg/m2 level 2, 800 mg/m2 level 3, 900 mg/m2 level 4, intravenous (IV), every 21 days, until disease progression Phase 2 - 700 mg/m2, intravenous (IV), every 21 days, until disease progression

cisplatinDRUG

75 mg/m2, intravenous (IV), every 21 days, until disease progression

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (8)

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.

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Objective Best Tumor Response

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

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)

Secondary Outcomes

Duration of Response

The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

Time frame: time of response to progressive disease or death (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)

Progression Free Survival

The period from study entry until disease progression or death on study, whichever occurred first.

Time frame: baseline to measured progressive disease or death (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)

Overall Survival

Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Time frame: baseline to date of death from any cause (Survival follow-up were performed every 2 cycles during therapy and approximately every 3 months during post-therapy until death or up to 12 months after enrollment)

Data from ClinicalTrials.gov

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