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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

pemetrexed

oxaliplatin

About this trial

This is an interventional treatment trial for Advanced Gastric Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00192088

First Posted

September 12, 2005

Last Updated

January 24, 2007

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00192088

Brief Title

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

Official Title

Open-Label Single-Arm Phase II Study of ALIMTA in Combination With Oxaliplatin as First-Line Therapy in Advanced Gastric Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Gastric Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

43 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

The secondary objectives of this study are to evaluate:

Title

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.

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Chair

Facility Information:

Facility Name