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

• Sponsor: NSABP Foundation Inc (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00314353
• Collaborator: Genentech, Inc. (Industry), Hoffmann-La Roche (Industry), International Drug Development Institute (Other)
• Enrollment: 7
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms	Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Irinotecan	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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.; Other Names: Avastin ; Drug: Oxaliplatin; 130 mg/m2 IV Day 1 every 21 days for eight cycles; Other Names: Eloxatin ; Drug: 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; Other Names: Xeloda
Experimental: 2	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.; Other Names: Avastin ; Drug: 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; Other Names: Xeloda ; Drug: Irinotecan; 200 mg/m2 IV Day 1 every 21 days for eight cycles; Other Names: Camptosar

Outcome Measures

Primary Outcome Measures

1. One-year Progression-free Survival (PFS) [Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.]

   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.

Secondary Outcome Measures

1. Objective Response Rate [Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.]

2. 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]

3. Overall Survival [Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.]

4. Duration of Response [Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NSABP Operations Center	Pittsburgh	Pennsylvania	United States	15212

Sponsors and Collaborators

• NSABP Foundation Inc
• Genentech, Inc.
• Hoffmann-La Roche
• International Drug Development Institute

Investigators

• Principal Investigator: Norman Wolmark, MD, NSABP Foundation Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NSABP Foundation Inc
• ClinicalTrials.gov Identifier: NCT00314353
• Other Study ID Numbers: NSABP FC-BV-003
• First Posted: Apr 13, 2006
• Last Update Posted: Oct 6, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by NSABP Foundation Inc: NSABP; bevacizumab; capecitabine; oxaliplatin; irinotecan; rectal cancer; colon cancer; colorectal cancer
• Additional relevant MeSH terms: Colorectal Neoplasms; Bevacizumab; Capecitabine; Oxaliplatin; Irinotecan

Study Results

Participant Flow

Arm/Group Title	Capecitabine, Oxaliplatin, Bevacizumab	Capecitabine, Irinotecan, Bevacizumab
Arm/Group Description
Period Title: Protocol Therapy (8 Cycles)
STARTED	4	3
COMPLETED	2	0
NOT COMPLETED	2	3
Period Title: Protocol Therapy (8 Cycles)
STARTED	3	0
COMPLETED	3	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Capecitabine, Oxaliplatin, Bevacizumab	Capecitabine, Irinotecan, Bevacizumab	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	4	3	7
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 50%	2 66.7%	4 57.1%
>=65 years	2 50%	1 33.3%	3 42.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.8 (9.0)	63.0 (13.2)	64.6 (10.1)
Sex: Female, Male (Count of Participants)
Female	1 25%	1 33.3%	2 28.6%
Male	3 75%	2 66.7%	5 71.4%
Region of Enrollment (participants) [Number]
United States	4 100%	3 100%	7 100%

Outcome Measures

1. Primary Outcome

Title	One-year Progression-free Survival (PFS)
Description	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.
Time Frame	Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Outcome Measure Data

Analysis Population Description

Primary 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.

Arm/Group Title	Capecitabine, Oxaliplatin, Bevacizumab	Capecitabine, Irinotecan, Bevacizumab
Arm/Group Description
Measure Participants	0	0

2. Secondary Outcome

Title	Objective Response Rate
Time Frame	Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Capecitabine, Oxaliplatin, Bevacizumab	Capecitabine, Irinotecan, Bevacizumab
Arm/Group Description
Measure Participants	0	0

3. Secondary Outcome

Title	Toxicity - Adverse Events
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Capecitabine, Oxaliplatin, Bevacizumab	Capecitabine, Irinotecan, Bevacizumab
Arm/Group Description
Measure Participants	0	0

4. Secondary Outcome

Title	Overall Survival
Time Frame	Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Capecitabine, Oxaliplatin, Bevacizumab	Capecitabine, Irinotecan, Bevacizumab
Arm/Group Description
Measure Participants	0	0

5. Secondary Outcome

Title	Duration of Response
Time Frame	Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Capecitabine, Oxaliplatin, Bevacizumab	Capecitabine, Irinotecan, Bevacizumab
Arm/Group Description
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	Adverse events were 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.
Arm/Group Title	Capecitabine, Oxaliplatin, Bevacizumab		Capecitabine, Irinotecan, Bevacizumab
Arm/Group Description
All Cause Mortality
	Capecitabine, Oxaliplatin, Bevacizumab		Capecitabine, Irinotecan, Bevacizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Capecitabine, Oxaliplatin, Bevacizumab		Capecitabine, Irinotecan, Bevacizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Capecitabine, Oxaliplatin, Bevacizumab		Capecitabine, Irinotecan, Bevacizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.