A Study of Pemetrexed Plus Oxaliplatin as First Line Therapy in Advanced Gastric Carcinoma

Tracking Information
First Submitted Date ICMJE	September 12, 2005
First Posted Date ICMJE	September 19, 2005
Last Update Posted Date	January 26, 2007
Study Start Date ICMJE	May 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: September 12, 2005)	The primary objective of this study is to determine the response rate of Pemetrexed plus oxaliplatin as first-line therapy in patients with advanced gastric carcinoma.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00192088 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 12, 2005)	The secondary objectives of this study are to evaluate:; The following time to event efficacy measures:Duration of overall response for responding patients-Time to documented progressive disease-Time to treatment failure-Overall survival-The quantitative and qualitative toxicity of pemetrexed plus oxaliplatin.; Determinants of efficacy and toxicity of the treatment with pemetrexed and oxaliplatin in the patient population by means of pharmacogenomic and pharmacogenetics investigations: Quantitative analysis of TS, DHFR, GARFT, RFC, MRP5, DPD, TP, FPGS and ERCC1
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study of Pemetrexed Plus Oxaliplatin as First Line Therapy in Advanced Gastric Carcinoma
Official Title ICMJE	Open-Label Single-Arm Phase II Study of ALIMTA in Combination With Oxaliplatin as First-Line Therapy in Advanced Gastric Carcinoma
Brief Summary	Open label single arm phase II study of Pemetrexed plus Oxaliplatin in patients with advanced gastric carcinoma not previously treated with palliative chemotherapy. 43 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: 6 cycles/21 days of Pemetrexed 500 mg/m2 followed by Oxaliplatin 120 mg/m2. This study will also include pharmacogenomic and pharmacogenetic investigations in order to assess determinants of efficacy and toxicity of the treatment with Pemetrexed and Oxaliplatin in the study population.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Advanced Gastric Carcinoma
Intervention ICMJE	Drug: pemetrexed; Drug: oxaliplatin
Study Arms	Not Provided
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
Enrollment ICMJE; (submitted: September 12, 2005)	43
Original Enrollment ICMJE	Same as current
Study Completion Date	May 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria; Histologically proven diagnosis of adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction); Stage IIIB or Stage IV disease, according to American Joint Committee on Cancer criteria, not amenable to curative surgery or radiation; Disease status must be that of at least of one measurable disease as defined by RECIST criteria.; Performance Status of 2 on the ECOG Scale.; Adequate organ function including the following:; Bone marrow: absolute neutrophil count (ANC) >or equal to 1.5 * 109/L, platelets >or equal to 100 *109/L, hemoglobin > or equal to 10 g/dL.; Hepatic: bilirubin < or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin > or equal to3g/dL.; Renal: Calculated creatinine clearance major or equal to 45 ml/min (using the standard Cockcroft-Gault formula). Exclusion Criteria; No Prior palliative chemotherapy for advanced disease; Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment; Known or suspected brain metastasis; Second primary malignancy (except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence); Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed plus oxaliplatin
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Italy
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00192088
Other Study ID Numbers ICMJE	8059; H3E-IT-S043
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Eli Lilly and Company
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9 am-5 pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account	Eli Lilly and Company
Verification Date	January 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP