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Colorectal NeoplasmsPhase 2NCT00615056

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

A Phase 2 study testing Bevacizumab (avastin), FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]) and AG-013736 (axitinib) in people with Colorectal Neoplasms, run by Pfizer at 83 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
Bevacizumab (avastin), FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]) and AG-013736 (axitinib)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
83 sitesin 8 countries
Study dates
Mar 2008to Apr 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Prior treatment in first line metastatic setting with more than one regimen
  • Prior irradiation of more than 25% of bone marrow.

Trial locations and contacts

83 sites in 8 countries.

83 sites in 8 countries

United States61 sites

  • Pfizer Investigational Site

    Antioch, California, 94531

  • Pfizer Investigational Site

    Atlanta, Georgia, 30318

  • Pfizer Investigational Site

    Aurora, Colorado, 80045

  • Pfizer Investigational Site

    Baltimore, Maryland, 21237

  • Pfizer Investigational Site

    Bonita Springs, Florida, 34135

  • Pfizer Investigational Site

    Bradenton, Florida, 34209

  • Pfizer Investigational Site

    Cape Coral, Florida, 33914

  • Pfizer Investigational Site

    Cape Coral, Florida, 33990

  • Pfizer Investigational Site

    Chattanooga, Tennessee, 37404

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45219

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45230

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45236

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45238

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45242

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45248

  • Pfizer Investigational Site

    Corpus Christi, Texas, 78463

  • Pfizer Investigational Site

    Crestview Hills, Kentucky, 41017

  • Pfizer Investigational Site

    Dubuque, Iowa, 52001

  • Pfizer Investigational Site

    Englewood, Florida, 34223

  • Pfizer Investigational Site

    Fairfield, Ohio, 45014

  • Pfizer Investigational Site

    Fort Myers, Florida, 33901-8108

  • Pfizer Investigational Site

    Fort Myers, Florida, 33905

  • Pfizer Investigational Site

    Fort Myers, Florida, 33908

  • Pfizer Investigational Site

    Fort Myers, Florida, 33916

  • Pfizer Investigational Site

    Franklin, Tennessee, 37067

  • Pfizer Investigational Site

    Gallatin, Tennessee, 37066

  • Pfizer Investigational Site

    Germantown, Tennessee, 38138

  • Pfizer Investigational Site

    Hamilton, Ohio, 45013

  • Pfizer Investigational Site

    Hermitage, Tennessee, 37076

  • Pfizer Investigational Site

    Hixson, Tennessee, 37343

  • Pfizer Investigational Site

    Lebanon, Tennessee, 37087

  • Pfizer Investigational Site

    Los Angeles, California, 90095-6984

  • Pfizer Investigational Site

    Los Angeles, California, 90095

  • Pfizer Investigational Site

    Mechanicsville, Virginia, 23116

  • Pfizer Investigational Site

    Midlothian, Virginia, 23114

  • Pfizer Investigational Site

    Mobile, Alabama, 36608

  • Pfizer Investigational Site

    Murfreesboro, Tennessee, 37130

  • Pfizer Investigational Site

    Naples, Florida, 34102

  • Pfizer Investigational Site

    Naples, Florida, 34119

  • Pfizer Investigational Site

    Nashville, Tennessee, 37203

  • Pfizer Investigational Site

    Nashville, Tennessee, 37205

  • Pfizer Investigational Site

    Nashville, Tennessee, 37207

  • Pfizer Investigational Site

    Nashville, Tennessee, 37211

  • Pfizer Investigational Site

    Nashville, Tennessee, 37232

  • Pfizer Investigational Site

    New Albany, Mississippi, 38652

  • Pfizer Investigational Site

    Paducah, Kentucky, 42002

  • Pfizer Investigational Site

    Paducah, Kentucky, 42003

  • Pfizer Investigational Site

    Paris, Tennessee, 38242

  • Pfizer Investigational Site

    Pleasant Hill, California, 94523

  • Pfizer Investigational Site

    Port Charlotte, Florida, 33980

  • Pfizer Investigational Site

    Richmond, Virginia, 23230

  • Pfizer Investigational Site

    Richmond, Virginia, 23235

  • Pfizer Investigational Site

    Ringgold, Georgia, 30736

  • Pfizer Investigational Site

    San Leandro, California, 94578

  • Pfizer Investigational Site

    Santa Monica, California, 90404

  • Pfizer Investigational Site

    Sarasota, Florida, 34232

  • Pfizer Investigational Site

    Sarasota, Florida, 34236

  • Pfizer Investigational Site

    Smyrna, Tennessee, 37167

  • Pfizer Investigational Site

    Union City, Tennessee, 38261

  • Pfizer Investigational Site

    Venice, Florida, 34285

  • Pfizer Investigational Site

    Venice, Florida, 34292

Other trials in United States

France4 sites

  • Pfizer Investigational Site

    Lille, 59020

  • Pfizer Investigational Site

    Montpellier, 34094

  • Pfizer Investigational Site

    Paris, 75012

  • Pfizer Investigational Site

    Villejuif, 94805

Other trials in France

Italy4 sites

  • Pfizer Investigational Site

    Genova, 16132

  • Pfizer Investigational Site

    Padova, 35128

  • Pfizer Investigational Site

    Roma, 00152

  • Pfizer Investigational Site

    Roma, 00168

Other trials in Italy

Canada3 sites

  • Pfizer Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • Pfizer Investigational Site

    Lévis, Quebec, G6V 3Z1

  • Pfizer Investigational Site

    Montreal, Quebec, H2X 3J4

Other trials in Canada

Japan3 sites

  • Pfizer Investigational Site

    Chuo-ku, Tokyo

  • Pfizer Investigational Site

    Kashiwa, Chiba

  • Pfizer Investigational Site

    Suntougun, Shizuoka

Other trials in Japan

South Korea3 sites

  • Pfizer Investigational Site

    Daegu, 700-721

  • Pfizer Investigational Site

    Jeollanam-do, 519-809

  • Pfizer Investigational Site

    Seoul, 139-706

Other trials in South Korea

Spain3 sites

  • Pfizer Investigational Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Pfizer Investigational Site

    Madrid, Madrid, 28033

  • Pfizer Investigational Site

    Sabadell, Barcelona, 08208

Other trials in Spain

Poland2 sites

  • Pfizer Investigational Site

    Warsaw, 02-097

  • Pfizer Investigational Site

    Warsaw, 02-781

Other trials in Poland

About this study

Official title: A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen

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.

Being tested
Bevacizumab (avastin), FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]), AG-013736 (axitinib), FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab (avastin)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])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.

  • AG-013736 (axitinib)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])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.

  • AG-013736 (axitinib)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])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.

  • Bevacizumab (avastin)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])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.

Study groups in NCT00615056
Study groupRoleWhat they receive
BActive comparatorBevacizumab (avastin)
Receives: Drug: Bevacizumab (avastin); Drug: FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU])
CExperimentalAG-013736 (axitinib)
Receives: Drug: AG-013736 (axitinib); Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])
AExperimentalAG-013736 (axitinib)
Receives: Drug: AG-013736 (axitinib); Drug: FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU])
DActive comparatorbevacizumab (avastin)
Receives: Drug: Bevacizumab (avastin); Drug: FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU])

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

    Measured: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks

Secondary outcomes (5)

  1. Overall Survival (OS)

    Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

    Measured: Baseline until death or up to 1 year after the randomization of last participant

  2. Percentage of Participants With Objective Response (OR)

    Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

    Measured: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks

  3. Duration of Response (DR)

    Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

    Measured: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks

  4. Change From Baseline in MD 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

    Symptom severity score is comprised of average of 14 MDASI-D core items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling and diarrhea) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last week; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. Total average score range: 0 to 10.

    Measured: 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

  5. 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

    Symptom Interference score is comprised of the average of 6 items on feeling or function from the MDASI-D core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last week; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. Total average score range: 0 to 10.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMar 2011
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00615056
Sponsor's protocol ID
A4061034
Status last verified
Apr 2013
First submitted
1 Feb 2008
Last updated
19 Apr 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab (avastin), FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]) and AG-013736 (axitinib) in people with Colorectal Neoplasms, run by Pfizer at 83 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, France, Italy, Canada, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00615056.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2013.

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