Irinotecan as 3rd Line Therapy in Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

A Phase II Study of Irinotecan as Single Agent in the Third Line Treatment of Unresectable or Metastatic Gastric Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02662959
• Other study ID #: Med Onc-G 01
• Status: Recruiting
• Phase: Phase 2
• First received: April 23, 2015
• Last updated: January 21, 2016
• Start date: April 2015

Study information

• Verified date: November 2015
• Source: Fudan University
• Contact: ZHIYU CHEN, M.D.
• Phone: +862164175590
• Email: zychan75[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable or metastatic disease at the time of diagnosis. Systemic therapy was required for the patients with advanced stage. Platinum combined with fluoropyrimidines always were considered as first line treatment. After failure of initial therapy, single agent of taxanes was used as second line treatment. However, there is no relative standard chemotherapeutic regimen in the third therapy except oral anti-angiogenesis drug-Apatinib. So this study was designed to explore the role of single agent with irinotecan as third line treatment in patients with metastatic gastric cancer in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed advanced or metastatic adenocarcinoma of the stomach

• Have failed for 2 lines of chemotherapy

• Life expectancy of more than 3 months

• ECOG performance scale = 2

• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)

• Duration from the last therapy is more than 6 weeks for nitroso or mitomycin

• More than 4 weeks for operation or radiotherapy

• More than 4 weeks for cytotoxic agents or growth inhibitors

• Adequate hepatic, renal, heart, and hematologic functions (platelets > 100 × 109/L, neutrophil > 1.5× 109/L, serum creatinine = 1×upper limit of normal(ULN), total bilirubin within 1× ULN, and serum transaminase=2.5×the ULN).

• Exclusion of pregnant or lactating women

Exclusion Criteria:

• Previously receiving irinotecan treatment

• Participated other clinical trials within 4 weeks

• Known Gilbert Syndrome or other biliary tract obstructive disease

• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

• Evidence of CNS metastasis

• Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure

• Receiving the therapy of thrombolysis or anticoagulation

• Disability of serious uncontrolled intercurrence infection.

• Uncontrolled pleural effusion and ascites

Study Design

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• Irinotecan
180 mg/m2, IV (in the vein) on day 1 of each 14 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Locations

Country	Name	City	State
China	Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	From the day enrolled in the study to death	1 year	No
Secondary	Progression free survival		6 month	No
Secondary	Objective Response Rate	evaluated by RECIST 1.1	8 weeks	No
Secondary	Number of Adverse Events		Participants will be followed for the duration of treatment interval, an expected average of two weeks	Yes