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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korean Cancer Study Group
• Collaborator: Boryung Pharmaceutical Co., Ltd
• Treatments: Albumin-Bound Paclitaxel; Camptothecin; Irinotecan; Paclitaxel

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