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

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

NCT ID: NCT01224652

Condition: Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms
Paclitaxel
Irinotecan

Conditions: Keywords:
gastric cancer
paclitaxel
irinotecan

Study type: Interventional

Study phase: Phase 3

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Paclitaxel
Description: 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
Arm group label: paclitaxel

Intervention type: Drug
Intervention name: Irinotecan
Description: 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
Arm group label: irinotecan

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:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Yonsei University Gangnam Severance Hospital

Address:
City: Seoul
Zip: 135-720
Country: Korea, Republic of

Status: Recruiting

Investigator:
Last name: Jae Yong Cho, M.D., Ph.D.
Email: Principal Investigator

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Country: Korea, Republic of

Status: Recruiting

Investigator:
Last name: Tae-You Kim, M.D., Ph.D.
Email: Principal Investigator

Lead sponsor:
Agency: Korean Cancer Study Group
Agency class: Other

Collaborator:
Agency: Boryung Pharmaceutical Co., Ltd
Agency class: Industry

Source: Korean Cancer Study Group

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01224652