Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

• ClinicalTrials.gov Identifier: NCT00320515
• Recruitment Status: Completed
• First Posted: May 3, 2006
• Results First Posted: September 28, 2009
• Last Update Posted: September 28, 2009
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

Tracking Information

• First Submitted Date: April 28, 2006
• First Posted Date: May 3, 2006
• Results First Submitted Date: July 9, 2009
• Results First Posted Date: September 28, 2009
• Last Update Posted Date: September 28, 2009
• Study Start Date: March 2004
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2009)

Objective Best Tumor Response [ 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) ]

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.

Original Primary Outcome Measures (submitted: April 28, 2006)

• The primary objective of the Phase 1 part of this study is to determine the dose of pemetrexed recommended for Phase 2
• The primary objective of the Phase 2 part of this study is to evaluate the objective response rate of pemetrexed-cisplatin in this patient population.

Current Secondary Outcome Measures (submitted: August 19, 2009)

• Duration of Response [ 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) ]
  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.
• Progression Free Survival [ 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) ]
  The period from study entry until disease progression or death on study, whichever occurred first.
• Overall Survival [ 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) ]
  Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Original Secondary Outcome Measures (submitted: April 28, 2006)

• The secondary objective of the Phase 1 part of this study is to evaluate the dose-limiting toxicity of pemetrexed-cisplatin
• The secondary objectives of the Phase 2 part of the study are to evaluate the following efficacy measures
• Duration of response for responding patients
• Progression Free Survival
• Overall survival
• The association between the clinical outcome of pemetrexed-cisplatin therapy, and MTHFR genotype
• A secondary objective of both Phase 1 and 2 is to evaluate the quantitative and qualitative toxicity of pemetrexed-cisplatin in this patient population.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer
• Official Title: Phase 1/2 Study of Pemetrexed Plus Cisplatin in Unresectable, Advanced Gastric Carcinoma.
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neoplasm, Gastric

Intervention

• Drug: pemetrexed

  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

  Other Names:

  • LY231514
  • Alimta
• Drug: cisplatin
  75 mg/m2, intravenous (IV), every 21 days, until disease progression

Study Arms

Experimental: A

Interventions:

• Drug: pemetrexed
• Drug: cisplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 19, 2009): 89
• Original Enrollment (submitted: April 28, 2006): 75
• Actual Study Completion Date: July 2008
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Korea, Republic of, Mexico, Taiwan

Administrative Information

• NCT Number: NCT00320515
• Other Study ID Numbers: 7461; H3E-AA-S038
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Chief Medical Officer, Eli Lilly
• Study Sponsor: Eli Lilly and Company
• Collaborators: Not Provided

Investigators

• Study Director: 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); Eli Lilly and Company

• PRS Account: Eli Lilly and Company
• Verification Date: August 2009