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A Phase II Study of Pazopanib in Combination With Capecitabine and Oxaliplatin (CAPEOX) in Patients With Advanced Gastric Cancer

Phase 2
18 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

A Phase II Study of Pazopanib in Combination With Capecitabine and Oxaliplatin (CAPEOX) in Patients With Advanced Gastric Cancer

Despite improvements in the early diagnosis of gastric cancer, many patients present with
inoperable disease and an effective, novel combination treatment is urgently needed for
these patients population. A recent meta-analysis demonstrated that chemotherapy improves
survival for patients with advanced gastric cancer compared with best supportive care alone
[hazard ratio (HR) 0.39, 95% confidence interval (CI) 0.28-0.52] and that combination
chemotherapy is superior to monotherapy (HR 0.83, 95% CI 0.74-0.93) (Wagner et al., 2006).
For advanced gastric cancer, 5-FU in combination with cisplatin (FP regimen) is commonly
used reference regimen, which are successfully replaced by capecitabine and oxaliplatin in
recent phase III trial (Cunningham et al., 2008; Okines et al., 2009). In phase II trial,
CAPEOX (capecitabine combined with oxaliplatin) regimen also showed promising activity for
the metastatic gastric cancer (Park et al., 2006; Park et al., 2008). In order to improve
survival of metastatic gastric cancer patients, various clinical trials incorporated novel
molecularly targeted agent in combination with the reference arm.

Inclusion Criteria:

- Subjects who provide written informed consent

- Age over 18 years

- Histologically proven unresectable gastric cancer

- ECOG performance status of 0-2

- At least one uni-dimensionally measurable lesion by RECIST criteria ver 1.1

- Adequate organ system function absolute neutrophil count > 1,500/µL, platelets >
100,000/µL, hemoglobin > 9g/dl Total bilirubin < 1.5 times upper limit of normal
(ULN), AST and ALT < 2.5 times ULN, PT (INR), PTT < 1.2 times UNL Serum creatinine
less than 1.5 mg/dL or Calculated Ccr at least 50 mL/min, Urine Protein to Creatinine
Ratio (UPC) less than 1

- female with Non-childbearing potential

Exclusion Criteria:

- Prior malignancy

- History or clinical evidence of central nervous system (CNS) metastases or
leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS
metastases, are asymptomatic, and have had no requirement for steroids or
anti-seizure medication for 6 months prior to first dose of study drug

- Clinically significant gastrointestinal abnormalities that may increase the risk for
gastrointestinal bleeding including

- Clinically significant gastrointestinal abnormalities that may affect absorption of
investigational product

- Presence of uncontrolled infection

- Corrected QT interval (QTc) above 480 msecs using Bazett's formula

- History of any one or more of the following cardiovascular conditions within the past
6 months: Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina,
Coronary artery bypass graft surgery, Symptomatic peripheral vascular disease, Class
II or higher congestive heart failure

- Poorly controlled hypertension while on antihypertensive agents

- History of cerebrovascular accident including transient ischemic attack (TIA),
pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months

- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or
presence of any non-healing wound, fracture, or ulcer

- Evidence of active bleeding or bleeding diathesis

- Hemoptysis within 6 weeks of first dose of study drug

- Any serious and/or unstable preexisting medical, psychiatric, or other condition that
could interfere with subject's safety, provision of informed consent, or compliance
to study procedures

- Unable or unwilling to discontinue use of prohibited medications listed in the

- Treatment with any of the following anti-cancer therapies;Radiation therapy, surgery
or tumor embolization within 14 days prior to the first dose of pazopanib; biologic
therapy, immunotherapy, investigational therapy or hormonal therapy within 14 days or
five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib;
No prior chemotherapy except adjuvant chemotherapy (Patients who received adjuvant
chemotherapy at least 6 months prior to study entry will be allowed regardless of
chemotherapeutic regimen

- Pre-existing grade 2 (or higher) motor or sensory neuropathy by CTCAE v4.0

- Known allergy to study drugs

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

6 months after last patient

Safety Issue:


Principal Investigator

Joon Oh Park, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

June 2015

Related Keywords:

  • Gastric Cancer
  • gastric cancer pazopanib capecitabine, oxaliplatin
  • Metastatic or recurrent gastric cancer
  • Stomach Neoplasms