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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

progression-free survival

Outcome Description:

Tumor evaluation using RECIST v1.1

Outcome Time Frame:

every 8 weeks

Safety Issue:

No

Principal Investigator

Tae-You Kim, M.D., Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Korean Cancer Stusy Group stomach Cancer Committee

Authority:

Korea: Ministry for Health, Welfare and Family Affairs

Study ID:

KCSG-ST10-01

NCT ID:

NCT01224652

Start Date:

Completion Date:

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • paclitaxel
  • irinotecan
  • Stomach Neoplasms

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