S-1 and Bevacizumab in Treating Patients With Colorectal Cancer That is Recurrent or Cannot Be Removed by Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00974389
First received: September 9, 2009
Last updated: August 9, 2013
Last verified: September 2009
  Purpose

RATIONALE: Drugs used in chemotherapy, such as S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving S-1 together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving S-1 together with bevacizumab works as third-line therapy in treating patients with colorectal cancer that is recurrent or that cannot be removed by surgery.


Condition Intervention Phase
Colorectal Cancer
Biological: bevacizumab
Drug: tegafur-gimeracil-oteracil potassium
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Combination Chemotherapy With S-1 Plus Avastin in Unresectable or Recurrent Colorectal Cancer After Failure of Prior Chemotherapy, Including Irinotecan and Oxaliplatin Regimens.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-control rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To evaluate giving S-1 with bevacizumab to see how well it works as third-line therapy in KRAS-mutation patients with unresectable or recurrent colorectal cancer.

OUTLINE: Patients receive oral S-1 twice daily on days 1-28 and bevacizumab IV on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal carcinoma

    • Inoperable, locally advanced, or metastatic disease
    • KRAS-mutated
  • Concurrently receiving treatment containing irinotecan and oxaliplatin regimens for unresectable or recurrent colorectal cancer
  • Measurable disease according to RECIST
  • No moderate or severe ascites or pleural effusion requiring treatment
  • No metastasis to the CNS

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • White blood cell count > 3,500/mm³ but < 12,000/mm³
  • Neutrophil count > 1,500/mm³
  • Hemoglobin > 9.0 g/dL
  • Platelet count > 100,000/mm³
  • Total bilirubin < 1.5 mg/dL
  • AST and ALT < 100 U/L (< 200 U/L in patients with liver metastasis)
  • Serum creatinine < 1.2 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • Urine dipstick for proteinuria < 1+
  • INR < 1.5
  • Not pregnant or nursing
  • Able to take capsules orally
  • No active second cancer
  • No active infections (e.g., patients with pyrexia of ≥ 38°C)
  • No serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, poorly controlled diabetes, or hypertension)
  • No electrocardiographic abnormalities with cardiac disorder that would clinically preclude the execution of the study as judged by the investigator
  • No serious drug hypersensitivity or a history of drug allergy
  • No thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
  • No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
  • No clinically significant traumatic injury within the past 4 weeks
  • No severe mental disorder

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent low-dose aspirin therapy (< 325 mg/day) allowed
  • More than 4 weeks since prior major surgical procedure or open biopsy
  • No prior therapy radiotherapy
  • No prior therapy with S-1
  • No prior chemotherapy include irinotecan and oxaliplatin as first- or second-line treatment.
  • No concurrent continuous treatment with steroids
  • No concurrent treatment with flucytosine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974389

Locations
Japan
Osaka Medical College Recruiting
Takatsuki, Osaka, Japan, 569-8686
Contact: Hiroya Takiuchi, MD, PhD    81-72-683-1221      
Sponsors and Collaborators
Osaka Medical College
Investigators
Principal Investigator: Hiroya Takiuchi, MD, PhD Osaka Medical College
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00974389     History of Changes
Other Study ID Numbers: OSAKA-TRICC0901, CDR0000649021
Study First Received: September 9, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage III rectal cancer
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Tegafur
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014