search
Back to results

Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
irinotecan and cisplatin
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring advanced gastric cancer, irinotecan, cisplatin

Eligibility Criteria

18 Years - 70 Years (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 III or Stage IV disease, according to American Joint Committee on Cancer criteria
  • Patients with UGT1A1*28 genotype 6/6 or 6/7
  • Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale
  • Previous adjuvant or pre-operative chemotherapy without containing irinotecan or platinum at least 6 months before enrollment
  • 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 60 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

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single-arm Irinotecan-Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate
The primary objective of this study is to determine the response rate of CPT11 plus cisplatin as first-line therapy in patients with advanced gastric carcinoma.

Secondary Outcome Measures

Time to event efficacy
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 Overall survival The quantitative and qualitative toxicity of irinotecan plus cisplatin. Determinants of efficacy and toxicity of the treatment with irinotecan and cisplatin in the patient population by means of pharmacogenomic investigations: Quantitative analysis of UGT1A1 and ERCC1

Full Information

First Posted
September 25, 2011
Last Updated
May 2, 2014
Sponsor
Chinese Academy of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01444521
Brief Title
Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer
Official Title
Genotype-drive Phase II Study of Novel Irinotecan-Cisplatin Combination as First-line Therapy for Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal dosage of combination chemotherapy.
Detailed Description
Open label single arm phase II study of cisplatin and irinotecan in patients with advanced gastric carcinoma not previously treated with palliative chemotherapy. 40 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: 8 cycles/14 days of irinotecan 125 mg/m2 on Day 1 and cisplatin 50 mg/m2 on Day2. This study will also include genotype investigations of UGT1A1 and ERCC1 expression in order to assess determinants of efficacy and toxicity of the treatment with cisplatin and irinotecan in the study population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
advanced gastric cancer, irinotecan, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single-arm Irinotecan-Cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
irinotecan and cisplatin
Other Intervention Name(s)
CAMPT
Intervention Description
irinotecan 125 mg/m2 will be administered as an intravenous (IV) infusion over half a hour on Days 1; Cisplatin 60 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day. 14 days as a cycle, up to 8 cycles.
Primary Outcome Measure Information:
Title
Overall response rate
Description
The primary objective of this study is to determine the response rate of CPT11 plus cisplatin as first-line therapy in patients with advanced gastric carcinoma.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to event efficacy
Description
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 Overall survival The quantitative and qualitative toxicity of irinotecan plus cisplatin. Determinants of efficacy and toxicity of the treatment with irinotecan and cisplatin in the patient population by means of pharmacogenomic investigations: Quantitative analysis of UGT1A1 and ERCC1
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven diagnosis of adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction) Stage III or Stage IV disease, according to American Joint Committee on Cancer criteria Patients with UGT1A1*28 genotype 6/6 or 6/7 Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale Previous adjuvant or pre-operative chemotherapy without containing irinotecan or platinum at least 6 months before enrollment 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 60 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Huang, M.D.,Ph.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15865075
Citation
Koizumi W, Kurihara M, Satoh A, Takiuchi H, Tanabe S, Shimada K, Iwasaki R, Saigenji K. Phase 1/11 study of bi-weekly irinotecan plus cisplatin in the treatment of advanced gastric cancer. Anticancer Res. 2005 Mar-Apr;25(2B):1257-62.
Results Reference
result
PubMed Identifier
21740478
Citation
Satoh T, Ura T, Yamada Y, Yamazaki K, Tsujinaka T, Munakata M, Nishina T, Okamura S, Esaki T, Sasaki Y, Koizumi W, Kakeji Y, Ishizuka N, Hyodo I, Sakata Y. Genotype-directed, dose-finding study of irinotecan in cancer patients with UGT1A1*28 and/or UGT1A1*6 polymorphisms. Cancer Sci. 2011 Oct;102(10):1868-73. doi: 10.1111/j.1349-7006.2011.02030.x. Epub 2011 Aug 12.
Results Reference
result

Learn more about this trial

Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer

We'll reach out to this number within 24 hrs