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

NCT ID: NCT01444521

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-05-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single-arm Irinotecan-Cisplatin

Group Type: EXPERIMENTAL

irinotecan and cisplatin

Intervention Type: DRUG

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.

Interventions

irinotecan and cisplatin

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.

Intervention Type: DRUG

Other Intervention Names

CAMPT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jing Huang

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Huang, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

References

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.

Reference Type: RESULT

PMID: 15865075 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21740478 (View on PubMed)

Other Identifiers

CH-GI-017

Identifier Type: -

Identifier Source: org_study_id