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.
20 Years
80 Years
Both
Colorectal Cancer
Trial Information
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.
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease-control rate
Safety Issue:
No
Principal Investigator
Hiroya Takiuchi, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Osaka Medical College
Authority:
Unspecified
Study ID:
CDR0000649021
NCT ID:
NCT00974389
Start Date:
July 2009
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage III colon cancer
- stage III rectal cancer
- stage IV colon cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- Colorectal Neoplasms
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