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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00569335
First received: December 5, 2007
Last updated: November 1, 2012
Last verified: November 2012

December 5, 2007
November 1, 2012
October 2007
March 2010   (final data collection date for primary outcome measure)
Safety [ Time Frame: any time ] [ Designated as safety issue: Yes ]
Safety [ Time Frame: 2 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00569335 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Progression-free survival, Response rate, Overall survival, Time to treatment failure, Treatment situation [ Time Frame: 2 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase II Trial of Combination Therapy With S-1, Irinotecan, and Bevacizumab (SIRB) in Patients With Unresectable or Recurrent Colorectal Cancer
Phase II Trial of Combination Therapy With S-1, Irinotecan, and Bevacizumab (SIRB) in Patients With Unresectable or Recurrent Colorectal Cancer

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal, Cancer
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.

Experimental: 1
S-1, Irinotecan, Bevacizumab
Intervention: Drug: S-1, Irinotecan, Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00569335
01023020
Yes
Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Yasuhide Yamada National Cancer Center Hospital
Taiho Pharmaceutical Co., Ltd.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP