Phase II Trial of Combination Therapy With S-1, Irinotecan, and Bevacizumab (SIRB) in Patients With Unresectable or Recurrent Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569335
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : November 2, 2012
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Brief Summary:
Phase II trial of combination therapy with S-1, irinotecan, and bevacizumab (SIRB) in patients with unresectable or recurrent colorectal cancer

Condition or disease Intervention/treatment Phase
Colorectal, Cancer Drug: S-1, Irinotecan, Bevacizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Combination Therapy With S-1, Irinotecan, and Bevacizumab (SIRB) in Patients With Unresectable or Recurrent Colorectal Cancer
Study Start Date : October 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
S-1, Irinotecan, Bevacizumab
Drug: S-1, Irinotecan, Bevacizumab

S-1 is administered orally on days 1 to 14 of a 21-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).

Irinotecan 150 mg/m2 is administered by intravenous infusion on day 1. Bevacizumab 7.5 mg/kg (body weight) is administered by intravenous infusion on day 1.

Primary Outcome Measures :
  1. Safety [ Time Frame: any time ]

Secondary Outcome Measures :
  1. Progression-free survival, Response rate, Overall survival, Time to treatment failure, Treatment situation [ Time Frame: every course for first three courses, then every other course ]

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
  2. Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
  3. Patients with no previous treatment (radiotherapy or chemotherapy). Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.

    Preoperative or postoperative irradiation (<30 Gy) for rectal cancer is possible

  4. Age >20 years
  5. Life expectancy of at least 3 months
  6. ECOG PS of 0 or 1
  7. Adequate function of major organs as defined below:

    1. Hemoglobin >9.0 g/dL
    2. White blood cell count >3,000/mm3
    3. Neutrophil count >1,500/mm3
    4. Platelet count >100,000/mm3
    5. Total bilirubin <1.5 mg/dL
    6. AST and ALT <100 U/L (<200 U/L in patients with liver metastasis)
    7. Serum creatinine <1.2 mg/dL
    8. Creatinine clearance estimate by the Cockcroft-Gault method >50 mL/min (reduce initial dosage by one step if ≥50 but <80 mL/min)
  8. Able to take capsules orally.
  9. No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
  10. Voluntary written informed consent.

Exclusion Criteria:

  1. Serious drug hypersensitivity or a history of drug allergy
  2. Active double cancer
  3. Active infections (e.g., patients with pyrexia of 38℃ or higher)
  4. History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
  5. Uncontrolled hypertension
  6. Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
  7. Moderate or severe ascites or pleural effusion requiring treatment
  8. Watery diarrhea
  9. Treatment with flucytosine or atazanavir sulfate
  10. Metastasis to the CNS
  11. Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
  12. Severe mental disorder
  13. Continuous treatment with steroids
  14. Urine dipstick for proteinuria should be <2+
  15. Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
  16. Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
  17. Long-term daily treatment with aspirin (>325 mg/day)
  18. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
  19. Judged ineligible for participation in the study by the investigator for safety reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00569335

National Cancer Center Hospital
Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Principal Investigator: Yasuhide Yamada National Cancer Center Hospital

Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00569335     History of Changes
Other Study ID Numbers: 01023020
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: November 2012

Keywords provided by Taiho Pharmaceutical Co., Ltd.:
S-1, Bevacizumab, Irinotecan

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action