Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy

Gastric Cancer Clinical Trial

Official title:

A Randomized, Multicenter Phase III Study to Assess the Efficacy of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01224652
• Other study ID #: KCSG-ST10-01
• Status: Recruiting
• Phase: Phase 3
• First received: October 14, 2010
• Last updated: October 19, 2010

Study information

• Verified date: October 2010
• Source: Korean Cancer Study Group
• Contact: Tae-You Kim, M.D., Ph.D.
• Phone: 82-2-2072-3943
• Email: kimty[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study is to compare the efficacy of paclitaxel monotherapy with irinotecan monotherapy as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first line therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 518
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed gastric adenocarcinoma in tissue/cell

• Recurrent or metastatic gastric cancer that has progressed following first- line therapy

• Patients must be =18 years of age.

• ECOG performance status = 2

• At least one lesion (measurable or non-measurable but evaluable) according to RECIST criteria

• Normal organ and bone marrow function measured within 2 weeks prior to administration of study treatment as defined below: Haemoglobin = 9.0 g/dL White blood cells (WBC) = 3000/µL Absolute neutrophil count (ANC) = 1500/µL Platelet count = 100 x 103/µL Total bilirubin = 1.5 x upper normal limit (UNL) Creatinine clearance = 60 ml/min or Serum creatinine = 1.5 x UNL AST (SGOT)/ALT (SGPT) = 2.5 x UNL unless liver metastases are present in which case it must be = 5x UNL

• Life expectancy = 12 weeks.

• Written informed consent

• Provision of informed consent for genetic research (In case of optional genetic research)

Exclusion Criteria:

• More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting.

• Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used).

• Any previous treatment with a taxane, including paclitaxel and docetaxel or irinotecan, in the metastatic or recurrent setting.

• Patients with second primary cancer, except: adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for =5 years.

• Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used).

• Ongoing toxicities (>CTCAE grade 2) caused by previous cancer therapy.

• Clinically proven gastric outlet obstruction or CTCAE grade 3 or grade 4 upper GI bleeding

• Medically uncontrolled, clinically significant heart disease or infection

• Patients with symptomatic uncontrolled brain metastases.

• Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.

• Women who have pregnancy potential or willing to pregnant. Pregnant and breastfeeding women.

• Others Poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection Any psychiatric disorder that prohibits obtaining informed consent and regular follow-up. Inappropriate patient for subjects of this study on investigator's judgment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Paclitaxel
Paclitaxel, 70 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 28-day cycle
• Irinotecan
irinotecan 150 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1 and 15 of a 28-day cycle

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Gangnam Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korean Cancer Study Group	Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	Tumor evaluation using RECIST v1.1	every 8 weeks	No
Secondary	Safety	Number of Participants and toxicity grade accordong to NCI-CTCAE v3.0 as a Measure of Safety	up to 4 weeks after last administration of chemotherapy	Yes
Secondary	Overall survival		1 year	No