MedDataX Logo

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

NCT ID: NCT00615056

Last Updated: 2013-04-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer

NCT01765582

Colorectal Neoplasms
TERMINATED PHASE2

A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer

NCT05945901

Colorectal Cancer
ACTIVE_NOT_RECRUITING PHASE2/PHASE3

FOLFOXIRI + Bev + Atezo vs FOLFOXIRI + Bev as First-line Treatment of Unresectable Metastatic Colorectal Cancer Patients

NCT03721653

Metastatic Colorectal Cancer
COMPLETED PHASE2

A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer

NCT00192075

Colorectal Cancer
COMPLETED PHASE2

First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX

NCT00384176

Colorectal Cancer
COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

B

Bevacizumab (avastin)

Group Type ACTIVE_COMPARATOR

Bevacizumab (avastin)

Intervention Type DRUG

Bevacizumab intravenous \[IV\] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.

FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])

Intervention Type DRUG

Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous \[IV\] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

C

AG-013736 (axitinib)

Group Type EXPERIMENTAL

AG-013736 (axitinib)

Intervention Type DRUG

Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.

FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Intervention Type DRUG

Oxaliplatin (85 mg/m²) intravenous infusion \[IV\] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

A

AG-013736 (axitinib)

Group Type EXPERIMENTAL

AG-013736 (axitinib)

Intervention Type DRUG

Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.

FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])

Intervention Type DRUG

Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) IV and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

D

bevacizumab (avastin)

Group Type ACTIVE_COMPARATOR

Bevacizumab (avastin)

Intervention Type DRUG

Bevacizumab intravenous infusion \[IV\] 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.

FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Intervention Type DRUG

Oxaliplatin (85 mg/m²) IV infusion over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bevacizumab (avastin)

Bevacizumab intravenous \[IV\] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.

Intervention Type DRUG

FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])

Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous \[IV\] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

Intervention Type DRUG

AG-013736 (axitinib)

Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.

Intervention Type DRUG

FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Oxaliplatin (85 mg/m²) intravenous infusion \[IV\] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

Intervention Type DRUG

AG-013736 (axitinib)

Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.

Intervention Type DRUG

FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])

Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) IV and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

Intervention Type DRUG

Bevacizumab (avastin)

Bevacizumab intravenous infusion \[IV\] 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.

Intervention Type DRUG

FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

Oxaliplatin (85 mg/m²) IV infusion over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically documented colorectal cancer plus one of the following:
* Failure of one prior irinotecan- or oxaliplatin-containing regimen, or
* Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.

Exclusion Criteria

* Prior treatment in first line metastatic setting with more than one regimen
* Prior irradiation of more than 25% of bone marrow.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Mobile, Alabama, United States

Site Status

Pfizer Investigational Site

Antioch, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Pleasant Hill, California, United States

Site Status

Pfizer Investigational Site

San Leandro, California, United States

Site Status

Pfizer Investigational Site

Santa Monica, California, United States

Site Status

Pfizer Investigational Site

Aurora, Colorado, United States

Site Status

Pfizer Investigational Site

Bonita Springs, Florida, United States

Site Status

Pfizer Investigational Site

Bradenton, Florida, United States

Site Status

Pfizer Investigational Site

Cape Coral, Florida, United States

Site Status

Pfizer Investigational Site

Cape Coral, Florida, United States

Site Status

Pfizer Investigational Site

Englewood, Florida, United States

Site Status

Pfizer Investigational Site

Fort Myers, Florida, United States

Site Status

Pfizer Investigational Site

Fort Myers, Florida, United States

Site Status

Pfizer Investigational Site

Fort Myers, Florida, United States

Site Status

Pfizer Investigational Site

Fort Myers, Florida, United States

Site Status

Pfizer Investigational Site

Naples, Florida, United States

Site Status

Pfizer Investigational Site

Naples, Florida, United States

Site Status

Pfizer Investigational Site

Port Charlotte, Florida, United States

Site Status

Pfizer Investigational Site

Sarasota, Florida, United States

Site Status

Pfizer Investigational Site

Sarasota, Florida, United States

Site Status

Pfizer Investigational Site

Venice, Florida, United States

Site Status

Pfizer Investigational Site

Venice, Florida, United States

Site Status

Pfizer Investigational Site

Atlanta, Georgia, United States

Site Status

Pfizer Investigational Site

Ringgold, Georgia, United States

Site Status

Pfizer Investigational Site

Dubuque, Iowa, United States

Site Status

Pfizer Investigational Site

Crestview Hills, Kentucky, United States

Site Status

Pfizer Investigational Site

Paducah, Kentucky, United States

Site Status

Pfizer Investigational Site

Paducah, Kentucky, United States

Site Status

Pfizer Investigational Site

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

New Albany, Mississippi, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

Fairfield, Ohio, United States

Site Status

Pfizer Investigational Site

Hamilton, Ohio, United States

Site Status

Pfizer Investigational Site

Chattanooga, Tennessee, United States

Site Status

Pfizer Investigational Site

Franklin, Tennessee, United States

Site Status

Pfizer Investigational Site

Gallatin, Tennessee, United States

Site Status

Pfizer Investigational Site

Germantown, Tennessee, United States

Site Status

Pfizer Investigational Site

Hermitage, Tennessee, United States

Site Status

Pfizer Investigational Site

Hixson, Tennessee, United States

Site Status

Pfizer Investigational Site

Lebanon, Tennessee, United States

Site Status

Pfizer Investigational Site

Murfreesboro, Tennessee, United States

Site Status

Pfizer Investigational Site

Nashville, Tennessee, United States

Site Status

Pfizer Investigational Site

Nashville, Tennessee, United States

Site Status

Pfizer Investigational Site

Nashville, Tennessee, United States

Site Status

Pfizer Investigational Site

Nashville, Tennessee, United States

Site Status

Pfizer Investigational Site

Nashville, Tennessee, United States

Site Status

Pfizer Investigational Site

Paris, Tennessee, United States

Site Status

Pfizer Investigational Site

Smyrna, Tennessee, United States

Site Status

Pfizer Investigational Site

Union City, Tennessee, United States

Site Status

Pfizer Investigational Site

Corpus Christi, Texas, United States

Site Status

Pfizer Investigational Site

Mechanicsville, Virginia, United States

Site Status

Pfizer Investigational Site

Midlothian, Virginia, United States

Site Status

Pfizer Investigational Site

Richmond, Virginia, United States

Site Status

Pfizer Investigational Site

Richmond, Virginia, United States

Site Status

Pfizer Investigational Site

Greenfield Park, Quebec, Canada

Site Status

Pfizer Investigational Site

Lévis, Quebec, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Lille, , France

Site Status

Pfizer Investigational Site

Montpellier, , France

Site Status

Pfizer Investigational Site

Paris, , France

Site Status

Pfizer Investigational Site

Villejuif, , France

Site Status

Pfizer Investigational Site

Genova, , Italy

Site Status

Pfizer Investigational Site

Padua, , Italy

Site Status

Pfizer Investigational Site

Roma, , Italy

Site Status

Pfizer Investigational Site

Roma, , Italy

Site Status

Pfizer Investigational Site

Kashiwa, Chiba, Japan

Site Status

Pfizer Investigational Site

Suntougun, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Warsaw, , Poland

Site Status

Pfizer Investigational Site

Warsaw, , Poland

Site Status

Pfizer Investigational Site

Daegu, , South Korea

Site Status

Pfizer Investigational Site

Jeollanam-do, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Pfizer Investigational Site

Sabadell, Barcelona, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada France Italy Japan Poland South Korea Spain

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061034&StudyName=A%20Study%20Combining%20FOLFOX%20or%20FOLFIRI%20with%20AG-013736%20or%20Bevacizumab%20%28Avastin%29%20in%20Patients%20with%20Metastatic%20Colorectal%20Cancer%20After%20Failur

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A4061034

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer
NCT02138617 COMPLETED PHASE2
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
NCT00006115 UNKNOWN PHASE2
A Study of Bevacizumab, Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (A-FOLFOXIRI) Compared With Bevacizumab, Infusional Fluorouracil, Leucovorin, and Irinotecan/Oxaliplatin (A-FOLFIRI/FOLFOX) as First-line Treatment for Metastatic Right-sided Colon Cancer
NCT03641976 UNKNOWN PHASE2
Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer
NCT01321957 COMPLETED PHASE2
First-line FOLFOXIRI In Combination With Bevacizumab For Metastatic Colorectal Cancer
NCT01163396 COMPLETED PHASE2
A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
NCT01937715 TERMINATED PHASE1/PHASE2
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
NCT00278889 COMPLETED PHASE2
FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer
NCT05627635 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Bevacizumab Followed by FOLFIRI + Panitumumab (Sequence 2) in Untreated Patients With Wild-type RAS Metastatic, Primary Left-sided, Unresectable Colorectal Cancer
NCT03635021 ACTIVE_NOT_RECRUITING PHASE3
FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab as 1st Line Treatment of pMMR and IS IC-High Metastatic Colorectal Cancer Patients.
NCT06733038 RECRUITING PHASE3
A Study in Second Line Metastatic Colorectal Cancer
NCT01183780 COMPLETED PHASE3
A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer
NCT02141295 TERMINATED PHASE2
FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma
NCT00735241 WITHDRAWN PHASE2/PHASE3
Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients
NCT00354978 COMPLETED PHASE2
Study of 5-Fluorouracil/Leucovorin/Oxaliplatin (FOLFOX) + Bevacizumab Versus 5-Fluorouracil/Leucovorin/Oxaliplatin/Irinotecan (FOLFOXIRI) + Bevacizumab as First Line Treatment of Patients With Metastatic Colorectal Cancer Not Previously Treated and With Three or More Circulating Tumoral Cells
NCT01640405 COMPLETED PHASE3
A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients
NCT01183494 COMPLETED PHASE1
Second-line Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Fruquintinib Versus Doublet Chemotherapy (FOLFOX or FOLFIRI) Plus Bevacizumab in Metastatic Colorectal Cancer
NCT07150403 NOT_YET_RECRUITING PHASE2
A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer
NCT03750786 COMPLETED PHASE3
Curative Resectability of Not Optimally Resectable Liver and/or Lung Metastases From Colorectal Carcinoma (CRC) Under Intensified Chemotherapy
NCT01126866 TERMINATED PHASE2
FOLFIRI + Bevacizumab With or Without Dalteparin in First Line Treatment of Advanced Colorectal Cancer
NCT00323011 TERMINATED PHASE2
Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy
NCT00967616 COMPLETED PHASE2
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
NCT06750094 RECRUITING PHASE3
Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC
NCT00469443 COMPLETED PHASE3
Hepatic Arterial Infusion With FOLFOX Alone or in Combination With IV Chemotherapy in Colon Cancer With Liver Metastasis
NCT02345746 WITHDRAWN PHASE2
Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer
NCT00609622 TERMINATED PHASE2