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Genotype-drive Phase II Study of Novel Irinotecan-Cisplatin Combination as First-line Therapy for Advanced Gastric Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

Genotype-drive Phase II Study of Novel Irinotecan-Cisplatin Combination as First-line Therapy for Advanced Gastric Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome 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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Jing Huang, M.D.,Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Authority:

China: Ministry of Health

Study ID:

CH-GI-017

NCT ID:

NCT01444521

Start Date:

April 2011

Completion Date:

December 2012

Related Keywords:

  • Gastric Cancer
  • advanced gastric cancer
  • irinotecan
  • cisplatin
  • Stomach Neoplasms

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