A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen

This study has been completed.

Study NCT00615056 Information provided by Pfizer

First Received on February 1, 2008. Last Updated on April 27, 2012 History of Changes

Results First Received: March 28, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Colorectal Neoplasms
Interventions:	Drug: Bevacizumab (avastin) Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]) Drug: AG-013736 (axitinib) Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
Bevacizumab + FOLFIRI	Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
Axitinib + FOLFOX	Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
Bevacizumab + FOLFOX	Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.

Participant Flow: Overall Study

	Axitinib + FOLFIRI	Bevacizumab + FOLFIRI	Axitinib + FOLFOX	Bevacizumab + FOLFOX
STARTED	49	51	36	35
Treated	46	51	36	35
COMPLETED	0	0	0	0
NOT COMPLETED	49	51	36	35
Death	31	31	21	23
Lost to Follow-up	1	2	4	5
Unspecified	11	15	10	7
Objective progression or relapse	0	1	0	0
Withdrawal by Subject	0	1	1	0
Ongoing	3	1	0	0
Randomized but not treated	3	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Axitinib + FOLFIRI	Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
Bevacizumab + FOLFIRI	Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
Axitinib + FOLFOX	Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
Bevacizumab + FOLFOX	Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.

Baseline Measures

	Axitinib + FOLFIRI	Bevacizumab + FOLFIRI	Axitinib + FOLFOX	Bevacizumab + FOLFOX	Total
Number of Participants [units: participants]	49	51	36	35	171
Age, Customized [units: Participants]
18 to 44 years	5	6	3	1	15
45 to 64 years	30	34	21	22	107
Greater than and equal to 65 years	14	11	12	12	49
Gender [units: Participants]
Female	18	24	20	11	73
Male	31	27	16	24	98

Outcome Measures

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1. Primary:

Progression Free Survival (PFS) [ Time Frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks ]

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2. Secondary:

Overall Survival (OS) [ Time Frame: Baseline until death or up to 1 year after the randomization of last participant ]

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3. Secondary:

Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks ]

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4. Secondary:

Duration of Response (DR) [ Time Frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks ]

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5. Secondary:

Change From Baseline in Monroe Dunaway Anderson Symptoms Inventory Diarrhea (MDASI–D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal [ Time Frame: Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal ]

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6. Secondary:

Change From Baseline in MDASI–D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal [ Time Frame: Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00615056 History of Changes
Other Study ID Numbers:	A4061034
Study First Received:	February 1, 2008
Results First Received:	March 28, 2012
Last Updated:	April 27, 2012
Health Authority:	United States: Food and Drug Administration