Efficacy Study of Paclitaxel Versus Irinotecan in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, paclitaxel, irinotecan
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Paclitaxel Type: Drug
Name: Irinotecan Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Yonsei University Gangnam Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Sponsors
Korean Cancer Study Group
Source
Korean Cancer Study Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page