NCT01444521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

3.1 years

First QC Date

September 25, 2011

Last Update Submit

May 2, 2014

Conditions

Gastric Cancer

Keywords

advanced gastric canceririnotecancisplatin

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Time to event efficacy

    1 year

Study Arms (1)

single-arm Irinotecan-Cisplatin

EXPERIMENTAL
Drug: irinotecan and cisplatin

Interventions

irinotecan and cisplatinDRUG

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.

Also known as: CAMPT
single-arm Irinotecan-Cisplatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (2)

  • 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.

    PMID: 15865075RESULT

  • 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.

    PMID: 21740478RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

IrinotecanCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Jing Huang, M.D.,Ph.D

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 25, 2011

First Posted

September 30, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

CN(1)