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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paclitaxel<br>Paclitaxel 70 mg/m2 on Days 1, 8 and 15 of a 28-day cycle | Drug: Paclitaxel<br>* 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<br>|
| Experimental: irinotecan<br>irinotecan 150 mg/m2 on Days 1 and 15 of a 28-day cycle | Drug: Irinotecan<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | Tumor evaluation using RECIST v1.1 | every 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, paclitaxel, irinotecan