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

NCT00974389 | Unknown Phase 2

• 2 other identifiers: OSAKA-TRICC0901CDR0000649021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

stage III colon cancer; stage III rectal cancer; stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

• Disease-control rate

Secondary Outcomes (4)

• Response rate

• Progression-free survival

• Overall survival

• Safety

Interventions

bevacizumab BIOLOGICAL

tegafur-gimeracil-oteracil potassium DRUG

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Osaka Medical College: lead

Study Sites (1)

Osaka Medical College

Takatsuki, Osaka, 569-8686, Japan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hiroya Takiuchi, MD, PhD

  Osaka Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Last Updated: August 12, 2013

Record last verified: 2009-09

Locations

JP (1)