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History of Changes for Study: NCT00320515
Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer.
Latest version (submitted August 19, 2009) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 28, 2006 None (earliest Version on record)
2 May 24, 2006 Contacts/Locations and Study Status
3 June 19, 2006 Contacts/Locations, Study Status and Study Identification
4 July 28, 2006 Study Status and Contacts/Locations
5 August 24, 2006 Contacts/Locations and Study Status
6 September 14, 2006 Contacts/Locations and Study Status
7 October 16, 2006 Contacts/Locations and Study Status
8 November 17, 2006 Study Status and Contacts/Locations
9 December 12, 2006 Contacts/Locations and Study Status
10 February 12, 2007 Contacts/Locations and Study Status
11 April 20, 2007 Study Status, Contacts/Locations and References
12 May 14, 2007 Study Status, Contacts/Locations and Study Design
13 July 16, 2007 Contacts/Locations and Study Status
14 August 13, 2007 Recruitment Status, Study Status and Contacts/Locations
15 December 20, 2007 Outcome Measures, Arms and Interventions, Study Status, Oversight and Sponsor/Collaborators
16 July 23, 2008 Recruitment Status, Study Status and Study Design
17 August 19, 2009 Outcome Measures, Study Status, Results, Eligibility, Arms and Interventions and Study Design
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Study NCT00320515
Submitted Date:  April 28, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: 7461
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.
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2006
Overall Status: Recruiting
Study Start: March 2004
Primary Completion:
Study Completion: December 2008
First Submitted: April 28, 2006
First Submitted that
Met QC Criteria:
April 28, 2006
First Posted: May 3, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 28, 2006
Last Update Posted: May 3, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Eli Lilly and Company
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Neoplasm, Gastric
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 75
Open or close this module Arms and Interventions
Intervention Details:
Drug: pemetrexed
Drug: cisplatin
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The primary objective of the Phase 1 part of this study is to determine the dose of pemetrexed recommended for Phase 2
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.
Secondary Outcome Measures:
1. The secondary objective of the Phase 1 part of this study is to evaluate the dose-limiting toxicity of pemetrexed-cisplatin
2. The secondary objectives of the Phase 2 part of the study are to evaluate the following efficacy measures
3. Duration of response for responding patients
4. Progression Free Survival
5. Overall survival
6. The association between the clinical outcome of pemetrexed-cisplatin therapy, and MTHFR genotype
7. A secondary objective of both Phase 1 and 2 is to evaluate the quantitative and qualitative toxicity of pemetrexed-cisplatin in this patient population.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 RECIST criteria.
  • Performance status of 0 or 1 on 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.
Open or close this module Contacts/Locations
Central Contact Person: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Telephone: 1-317-615-4559
Study Officials: 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)
Study Director
Eli Lilly and Company
Locations: Argentina
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.
[Not yet recruiting]
Buenos Aires, Argentina
Contact:Contact: Eli Lilly
Korea, Republic of
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.
[Not yet recruiting]
Seoul, Korea, Republic of
Contact:Contact: Eli Lilly
Mexico
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.
[Not yet recruiting]
Durango, Mexico
Contact:Contact: Eli Lilly
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.
[Not yet recruiting]
Mexico City, Mexico
Contact:Contact: Eli Lilly
Taiwan
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.
[Not yet recruiting]
Kaohsiung, Taiwan
Contact:Contact: Eli Lilly
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.
[Not yet recruiting]
Tainan, Taiwan
Contact:Contact: Eli Lilly
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.
[Recruiting]
Taipei, Taiwan
Contact:Contact: Eli Lilly
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.
[Recruiting]
Tao-Yuan, Taiwan
Contact:Contact: Eli Lilly
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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