Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon

Colorectal Neoplasms Clinical Trial

Official title:

Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00314353
• Other study ID #: NSABP FC-BV-003
• Status: Terminated
• Phase: Phase 2
• Start date: March 2006
• Est. completion date: June 2010

Study information

• Verified date: October 2021
• Source: NSABP Foundation Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.

Description:

Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2010
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)

• Evidence of adequate organ function (such as liver, kidneys, etc.)

Exclusion Criteria:

• Diagnosis of anal cancer

• Patients who are candidates for surgery

• Patients who have received previous treatments

• Pregnant or lactating women

• History of chronic disease(s) or other serious medical conditions

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• Bevacizumab
7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
• Oxaliplatin
130 mg/m2 IV Day 1 every 21 days for eight cycles
• Capecitabine
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
• Irinotecan
200 mg/m2 IV Day 1 every 21 days for eight cycles

Locations

Country	Name	City	State
United States	NSABP Operations Center	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
NSABP Foundation Inc	Genentech, Inc., Hoffmann-La Roche, International Drug Development Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One-year Progression-free Survival (PFS)	Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.	Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Secondary	Objective Response Rate		Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Secondary	Toxicity - Adverse Events		Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
Secondary	Overall Survival		Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Secondary	Duration of Response		Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.