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

NCT00569699 | Completed Phase 2 DMC

• 1 other identifier: 01023019
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

S-1; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  every course for first three courses, then every other course

Secondary Outcomes (1)

• Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation

  any time

Study Arms (1)

1

EXPERIMENTAL

S-1, Bevacizumab

Drug: S-1, Bevacizumab

Interventions

S-1, Bevacizumab DRUG

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.

1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
• Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
• 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.
• Treatment with FOLFIRI and FOLFOX is not indicated.
• Age \>65 years
• Life expectancy of at least 3 months
• ECOG PS of 0, 1, or 2
• Adequate function of major organs as defined below:
• Hemoglobin \>9.0 g/dL
• White blood cell count \>3,500/mm3, \<12,000/mm3
• Neutrophil count \>1,500/mm3
• 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

You may not qualify if:

• Serious drug hypersensitivity or a history of drug allergy
• Active double cancer
• Active infections (e.g., patients with pyrexia of 38℃ or higher)
• Uncontrolled hypertension
• Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
• Moderate or severe ascites or pleural effusion requiring treatment
• Watery diarrhea
• Treatment with flucytosine
• Metastasis to the CNS
• Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
• Severe mental disorder
• Continuous treatment with steroids
• Urine dipstick for proteinuria should be \<2+
• Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
• Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Osaka Medical College Hospital

Takatsuki, Osaka, 569-8686, Japan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

S 1 (combination); 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

  Osaka Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 7, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 2, 2012

Record last verified: 2012-11

Locations

JP (1)