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Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

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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:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 28, 2006
First Posted Date  ICMJE May 3, 2006
Results First Submitted Date  ICMJE July 9, 2009
Results First Posted Date  ICMJE September 28, 2009
Last Update Posted Date September 28, 2009
Study Start Date  ICMJE March 2004
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasm, Gastric
Intervention  ICMJE
  • 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  ICMJE Experimental: A
Interventions:
  • Drug: pemetrexed
  • Drug: cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2009)
89
Original Enrollment  ICMJE
 (submitted: April 28, 2006)
75
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Korea, Republic of,   Mexico,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00320515
Other Study ID Numbers  ICMJE 7461
H3E-AA-S038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP