A Study of Pazopanib With CAPEOX in AGC Patients

This study is currently recruiting participants.
Verified June 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Joon Oh Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01130805
First received: May 25, 2010
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

In order to improve survival of metastatic gastric cancer patients, we plan to to conduct a phase II trial of CapeOx with 800 mg once-daily pazopanib as a first-line chemotherapy in metastatic gastric cancer patients.


Condition Intervention Phase
Gastric Cancer
Drug: Pazopanib in combination with capecitabine and oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Pazopanib in Combination With Capecitabine and Oxaliplatin (CAPEOX) in Patients With Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 6 months after last patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Metabolic response rate by PET-CT [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: May 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib in combination with capecitabine and oxaliplatin
Capecitabine 850 mg/m2 bid on day 1-14, Oxaliplatin 130 mg/m2 IV on day 1 and Pazopanib 800 mg once in a day on day 1-21, every 3 weeks
Drug: Pazopanib in combination with capecitabine and oxaliplatin
Capecitabine 850 mg/m2 bid on day 1-14, Oxaliplatin 130 mg/m2 IV on day 1 and Pazopanib 800 mg once in a day on day 1-21, every 3 weeks
Other Name: Capecitabine, Oxaliplatin, pazopanib

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 protocol
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130805

Contacts
Contact: Joon Oh Park, M.D., Ph.D. 82 2 3410 3459 oncopark@skku.edu
Contact: Hye Jin Jang, RN 82 2 3410 6859 hyejin1217.jang@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Joon Oh Park, M.D., Ph.D    82 2 3410 3459    oncopark@skku.edu   
Principal Investigator: Joon Oh Park, M.D., Ph.D.         
Sub-Investigator: Won Ki Kang, M.D., Ph.D.         
Sub-Investigator: Ho Yeong Lim, M.D., Ph.D.         
Sub-Investigator: Young Suk Park, M.D., Ph.D.         
Sub-Investigator: Se Hoon Park, M.D., Ph.D.         
Sub-Investigator: Jeeyun Lee, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Joon Oh Park, M.D., Ph.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Joon Oh Park, associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01130805     History of Changes
Other Study ID Numbers: 2010-03-068
Study First Received: May 25, 2010
Last Updated: June 12, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
gastric cancer pazopanib capecitabine, oxaliplatin
Metastatic or recurrent gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014