A Study of Pazopanib With CAPEOX in AGC Patients

NCT01130805 | Completed Phase 2

• 1 other identifier: 2010-03-068
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

gastric cancer pazopanib capecitabine, oxaliplatin; Metastatic or recurrent gastric cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  6 months after last patient

Secondary Outcomes (4)

• Progression free survival (PFS)

  one year

• Overall survival (OS)

  Two years

• Metabolic response rate by PET-CT

  1 month

• Toxicities

  6 months

Study Arms (1)

Pazopanib in combination with capecitabine and oxaliplatin

EXPERIMENTAL

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

Interventions

Pazopanib in combination with capecitabine and oxaliplatin DRUG

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

Also known as: Capecitabine, Oxaliplatin, pazopanib

Pazopanib in combination with capecitabine and oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (2)

• Kim ST, Lee J, Lee SJ, Park SH, Jung SH, Park YS, Lim HY, Kang WK, Park JO. Prospective phase II trial of pazopanib plus CapeOX (capecitabine and oxaliplatin) in previously untreated patients with advanced gastric cancer. Oncotarget. 2016 Apr 26;7(17):24088-96. doi: 10.18632/oncotarget.8175.

  PMID: 27003363 RESULT

• Kim ST, Ahn S, Lee J, Lee SJ, Park SH, Park YS, Lim HY, Kang WK, Kim KM, Park JO. Value of FGFR2 expression for advanced gastric cancer patients receiving pazopanib plus CapeOX (capecitabine and oxaliplatin). J Cancer Res Clin Oncol. 2016 Jun;142(6):1231-7. doi: 10.1007/s00432-016-2143-2. Epub 2016 Mar 16.

  PMID: 26983912 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Interventions

pazopanib; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Joon Oh Park, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 26, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

KR (1)