Metastatic Colorectal CancerPhase 3NCT00337389
Phase III Randomized Study of 5-FU, CoFactor, and Avastin vs. 5-FU, LV and Avastin for First-Line Colorectal Cancer.
A Phase 3 study testing 5- Fluorouracil (5-FU), bevacizumab (Avastin) and Leucovorin in people with Metastatic Colorectal Cancer and Colon Cancer, run by Mast Therapeutics, Inc. at 47 sites in 2 countries.
Trial summary
To compare the progression-free survival time (PFS) in patients treated with 5-FU modulated with CoFactor (plus bevacizumab) to 5-FU modulated with leucovorin (plus bevacizumab) in patients with Metastatic Colorectal Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- What is being tested?
- 5- Fluorouracil (5-FU), bevacizumab (Avastin) and Leucovorin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 47 sitesin 2 countries
- Study dates
- May 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Greater or equal to 18 years of age.
- Surgically incurable, metastatic disease from proven colon or rectal adenocarcinoma.
- Life expectancy of at least 3 months.
- Histologically confirmed metastatic disease. Histological confirmation may be waived if needle biopsy presents a significant risk to the subject and the clinical setting is clinically consistent with metastasis of colorectal cancer, e.g. surgical findings at laparotomy, or positive PET scan, synchronous histologically confirmed primary tumor with typical metastatic pattern (stage D disease). Waiver can only be granted by the Sponsor, and these cases will be kept to less than 10% of the total study population.
- Measurable disease. At least one unidimensionally measurable lesion with a diameter ≥10 mm using spiral CT scans (use of spiral CT must be documented in medical records and used consistently throughout the study) or ≥20 mm using conventional CT or MRI scans.
- No prior systemic chemotherapy or immunotherapy for metastatic or advanced local disease. However patients may have had radiosensitizing doses of fluoropyrimidines (only 5-FU or capecitabine, with or without leucovorin or levamisole is permitted) if completed 6 months prior to treatment on this protocol. No prior irinotecan or oxaliplatin in combination with radiotherapy is allowed.
Show all 9Show fewer
- Prior adjuvant therapy is allowed if completed more than 6 months prior to treatment on this protocol. Regimens which included oxaliplatin and irinotecan are allowed.
- ECOG Performance Status is 0-2 or Karnofsky performance level of 100-70.
- Willing and able to provide written informed consent.
Who cannot join
- Any prior exposure to bevacizumab.
- A known intolerance to fluoropyrimidine (5-FU, capecitabine, floxuridine, UFT) therapy suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency.
- Use of the following drugs are not permitted on the protocol: sorivudine (or other nucleoside analogue), or Brivudin™ (or other DPD inhibitor).
- Pregnancy or lactation. Women with a positive (or no) serum or urine pregnancy test within 15 days of Cycle 1 Week 1. Women must have been amenorrheic for at least 12 consecutive months to be considered to lack potential for child bearing.
- If sexually active and of child-bearing potential, failure to agree to use adequate contraception during this study and for 60 days after discontinuation of study medication.
- A concurrent infection, including diagnoses of FUO and evidence of possible central line sepsis (subjects must be afebrile at the start of therapy).
Show all 27Show fewer
- Any unstable oncologic emergency syndromes: superior vena cava syndrome, rising bilirubin needing stent placement, spinal cord compression, active bleeding, etc.
- History of CNS metastasis, or other brain tumor, or history of stroke.
- Radiation therapy within 6 weeks of Cycle 1 Week 1, or any radiation therapy which encompasses target lesions selected for this study unless those lesions have documented progression of disease.
- Major surgery, open biopsy, or significant traumatic injury within 4 weeks of Cycle 1 Week 1, or anticipated need for major surgical procedure during the course of the study.
- Fine needle aspiration or placement of a central line catheter within 7 days of Cycle 1 Week 1.
- Inadequate bone marrow, liver or kidney function defined as:
- Serum creatinine more than 1.5 times the upper limit of normal,
- Urine protein to creatinine ratio >1,
- Serum bilirubin > 2 times the upper limit of normal,
- ANC < 1.5 x 109/L,
- Hemoglobin < 9.0 g / dL
- Platelet count < 90 x 109/L,
- SGOT (AST) and SGPT (ALT) more than 3 times the upper limit of normal, or more than 5 times the upper limit of normal for subjects with documented liver metastases.
- Myocardial infarction, transient ischemic attack, cerebral bleeding, translumenal cardiac angiography or cardiac stent placement or other arterial thrombotic event within 12 months prior to Cycle 1 Week 1.
- Active, clinically significant cardiovascular or symptomatic arterial peripheral vascular disease [e.g., uncontrolled hypertension, congestive heart failure, claudication, unstable angina, symptomatic cardiac arrhythmia, or New York Heart Association (NYHA) Class 2 or greater].
- Presence of serious non-healing wounds, gastro-duodenal ulcers active by endoscopy, gastro-intestinal perforation or intra-abdominal abscess, skin ulcers, or bone fractures.
- INR >1.5 unless on therapeutic doses of oral anticoagulants (e.g. warfarin). If so, must have an in-range INR (usually between 2-3) on a stable dose of drug.
- Participation in another experimental drug study within 4 weeks prior to Cycle 1 Week 1.
- Known or suspected anaphylaxis reaction to leucovorin or any allergic reaction to a drug which, in the opinion of the Investigator, suggests an increased potential for a hypersensitivity to CoFactor or other study drug including excipients.
- Presence of organ allograft requiring immunosuppressive therapy.
- Unwilling or unable to comply with the study protocol or history of psychiatric disability judged by the investigator to preclude granting of informed consent.
Trial locations and contacts
47 sites in 2 countries.
47 sites in 2 countries
United States46 sites
Research Center In
Anaheim, California
Research Center In
Apple Valley, California
Research Center In
Baltimore, Maryland
Research Center In
Beverly Hills, California
Research Center In
Boynton Beach, Florida
Research Center In
Charleston, South Carolina
Research Center In
Chattanooga, Tennessee
Research Center In
Cherry Hill, New Jersey
Research Center In
Collierville, Tennessee
Research Center In
Columbia, South Carolina
Research Center In
Cranston, Rhode Island
Research Center In
East Setauket, New York
Research Center In
Farmington, New Mexico
Research Center In
Flint, Michigan
Research Center In
Florence, Alabama
Research Center In
Fort Worth, Texas
Research Center In
Free Soil, Michigan
Research Center In
Grand Rapids, Michigan
Research Center In
Greenville, North Carolina
Research Center In
Gurnee, Illinois
Research Center In
Hazard, Kentucky
Research Center In
Henderson, Nevada
Research Center In
Indianapolis, Indiana
Research Center In
Irvine, California
Research Center In
Jackson, Mississippi
Research Center In
Joliet, Illinois
Research Center In
Lacey, Washington
Research Center In
Las Vegas, Nevada
Research Center In
Merritt Island, Florida
Research Center In
Middletown, Ohio
Research Center In
Mission Hills, California
Research Center In
Ogden, Utah
Research Center In
Port Huron, Michigan
Research Center In
Port Saint Lucie, Florida
Research Center In
Poway, California
Research Center In
Rancho Mirage, California
Research Center In
Reno, Nevada
Mercy General Hospital
Sacramento, California, 95819
Research Center In
Sacramento, California
Research Center In
San Diego, California
Research Site In
San Diego, California
Research Center In
Skokie, Illinois
Research Center In
Tarpon Springs, Florida
Research Center In
Vista, California
Research Center In
Walla Walla, Washington
Research Center In
Wichita, Kansas
About this study
Official title: A Phase III Multi-Center Randomized Clinical Trial to Evaluate the Safety and Efficacy of CoFactor and 5-Fluorouracil (5-FU) Plus Bevacizumab Versus Leucovorin and 5-FU Plus Bevacizumab as Initial Treatment for Metastatic Colorectal Carcinoma
To compare the progression-free survival time (PFS) in patients treated with 5-FU modulated with CoFactor (plus bevacizumab) to 5-FU modulated with leucovorin (plus bevacizumab) in patients with Metastatic Colorectal Cancer.
- Conditions
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- Being tested
- 5- Fluorouracil (5-FU), bevacizumab (Avastin), Leucovorin, CoFactor (ANX-510)
- Keywords
- Metastatic, Colorectal, Cancer, CoFactor, Stage IV
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5- Fluorouracil (5-FU)Drug
bevacizumab (Avastin)Drug
LeucovorinDrug
CoFactor (ANX-510)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CoFactor, 5-FU, Avastin Receives: Drug: 5- Fluorouracil (5-FU); Drug: bevacizumab (Avastin); Drug: CoFactor (ANX-510) |
| 2 | Active comparator | Leucovorin, 5-FU, Avastin Receives: Drug: 5- Fluorouracil (5-FU); Drug: bevacizumab (Avastin); Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Secondary outcomes (3)
Response Rate
Overall Survival
Incidence and Severity of Adverse Events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mast Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- M. Wasif Saif, MD, MBBS, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337389
- Sponsor's protocol ID
- 510-05
- Status last verified
- Nov 2007
- First submitted
- 14 Jun 2006
- Last updated
- 19 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multi-Center Randomized Clinical Trial to Evaluate the Safety and Efficacy of CoFactor and 5-Fluorouracil (5-FU) Plus Bevacizumab Versus Leucovorin and 5-FU Plus Bevacizumab as Initial Treatment for Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00337389
- Acronym / sponsor ID
- 510-05
- Conditions
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- Keywords
- Metastatic, Colorectal, Cancer, CoFactor, Stage IV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Mast Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- First posted
- 16 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the progression-free survival time (PFS) in patients treated with 5-FU modulated with CoFactor (plus bevacizumab) to 5-FU modulated with leucovorin (plus bevacizumab) in patients with Metastatic Colorectal Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 5- Fluorouracil (5-FU), Drug: bevacizumab (Avastin), Drug: CoFactor (ANX-510)CoFactor, 5-FU, Avastin |
| 2 | Active comparator | Drug: 5- Fluorouracil (5-FU), Drug: bevacizumab (Avastin), Drug: LeucovorinLeucovorin, 5-FU, Avastin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Greater or equal to 18 years of age.
- Surgically incurable, metastatic disease from proven colon or rectal adenocarcinoma.
- Life expectancy of at least 3 months.
- Histologically confirmed metastatic disease. Histological confirmation may be waived if needle biopsy presents a significant risk to the subject and the clinical setting is clinically consistent with metastasis of colorectal cancer, e.g. surgical findings at laparotomy, or positive PET scan, synchronous histologically confirmed primary tumor with typical metastatic pattern (stage D disease). Waiver can only be granted by the Sponsor, and these cases will be kept to less than 10% of the total study population.
- Measurable disease. At least one unidimensionally measurable lesion with a diameter ≥10 mm using spiral CT scans (use of spiral CT must be documented in medical records and used consistently throughout the study) or ≥20 mm using conventional CT or MRI scans.
Key exclusion criteria (27 listed)
- Any prior exposure to bevacizumab.
- A known intolerance to fluoropyrimidine (5-FU, capecitabine, floxuridine, UFT) therapy suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency.
- Use of the following drugs are not permitted on the protocol: sorivudine (or other nucleoside analogue), or Brivudin™ (or other DPD inhibitor).
- Pregnancy or lactation. Women with a positive (or no) serum or urine pregnancy test within 15 days of Cycle 1 Week 1. Women must have been amenorrheic for at least 12 consecutive months to be considered to lack potential for child bearing.
- If sexually active and of child-bearing potential, failure to agree to use adequate contraception during this study and for 60 days after discontinuation of study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5- Fluorouracil (5-FU) | Drug | 1, 2 |
| bevacizumab (Avastin) | Drug | 1, 2 |
| Leucovorin | Drug | 2 |
| CoFactor (ANX-510) | Drug | 1 |
Primary outcome
Progression Free Survival
3 secondary outcomes
Response Rate
Overall Survival
Incidence and Severity of Adverse Events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2007.
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Wasif Saif, MD, MBBS study chair
Yale University
47 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5- Fluorouracil (5-FU), bevacizumab (Avastin) and Leucovorin in people with Metastatic Colorectal Cancer and Colon Cancer, run by Mast Therapeutics, Inc. at 47 sites in 2 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 9 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 19 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Serbia and Montenegro. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2007.