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

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: NCT00569699
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:
The purpose of this study is to determine whether S-1 and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 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 Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)
Study Start Date : October 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

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

S-1 is administered orally on days 1 to 28 of a 42-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 <1.25 m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).

Bevacizumab 5 mg/kg (body weight) is administered by intravenous infusion on days 1, and 15.

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: every course for first three courses, then every other course ]

Secondary Outcome Measures :
  1. Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation [ Time Frame: any time ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years and older   (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.
  4. Treatment with FOLFIRI and FOLFOX is not indicated.
  5. Age >65 years
  6. Life expectancy of at least 3 months
  7. ECOG PS of 0, 1, or 2
  8. Adequate function of major organs as defined below:

    1. Hemoglobin >9.0 g/dL
    2. White blood cell count >3,500/mm3, <12,000/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
  9. Able to take capsules orally.
  10. No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
  11. 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. Uncontrolled hypertension
  5. Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
  6. Moderate or severe ascites or pleural effusion requiring treatment
  7. Watery diarrhea
  8. Treatment with flucytosine
  9. Metastasis to the CNS
  10. Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
  11. Severe mental disorder
  12. Continuous treatment with steroids
  13. Urine dipstick for proteinuria should be <2+
  14. Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
  15. Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
  16. Long-term daily treatment with aspirin (>325 mg/day)
  17. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
  18. 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): NCT00569699

Osaka Medical College Hospital
Takatsuki, Osaka, Japan, 569-8686
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Principal Investigator: Hiroya Takiuchi Osaka Medical College Hospital

Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00569699     History of Changes
Other Study ID Numbers: 01023019
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.:

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