Colorectal CarcinomaPhase 2/3FASTNCT00735241
FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma
A Phase 2/3 study testing SIR-Spheres microspheres, FOLFOX6 cycles 1-3 and FOLFOX6 cycles 4 onwards in people with Colorectal Carcinoma and Liver Metastases, run by Sirtex Medical at 3 sites in United States.
Trial summary
This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), in combination with the biologic therapy Bevacizumab (Avastin), for the first-line treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma, Liver Metastases
- What is being tested?
- SIR-Spheres microspheres, FOLFOX6 cycles 1-3 and FOLFOX6 cycles 4 onwards
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 2/3
- 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
- Histologically confirmed adenocarcinoma of the colon or rectum.
- Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent.
- ECOG performance status 0 - 1.
- Adequate hematological, renal and hepatic function.
Who cannot join
- Evidence of ascites, cirrhosis, portal hypertension, main portal vein tumor involvement or thrombosis as determined by clinical or radiologic assessment.
- Any extra-hepatic metastases other than metastases in the lungs and/or bones and/or abdominal or hilar lymph nodes. Central nervous system (CNS) metastases are not allowed.
- Previous radiotherapy delivered to the upper abdomen.
- Peripheral neuropathy > grade 1 (NCI-CTCv3).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Carolinas Medical Center
Charlotte, North Carolina, 28208
William Beaumont Hospital
Royal Oak, Michigan, 48073
Sacred Heart Medical Center
Spokane, Washington, 99204
About this study
Official title: Pilot Study of FOLFOX6 Plus Sir-Spheres® Microspheres (Chemo-radiotherapy) in Combination With Bevacizumab (Avastin) as a First Line Treatment in Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma
This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), in combination with the biologic therapy Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from colorectal carcinoma in whom surgical resection is not feasible.
- Conditions
- Colorectal Carcinoma, Liver Metastases
- Being tested
- SIR-Spheres microspheres, FOLFOX6 cycles 1-3, FOLFOX6 cycles 4 onwards, Bevacizumab cycles 3 onwards
- Keywords
- colon cancer, colorectal cancer, liver metastases, SIR-Spheres Microspheres, yttrium-90, FOLFOX, Bevacizumab, chemo-radiation
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIR-Spheres microspheresDevice
SIR-Spheres yttrium-90 microspheres
FOLFOX6 cycles 1-3Drug
Also called Eloxatin, Folinic acid, 5-FU
Oxaliplatin 60 mg/m2, IV infusion, q 2 weeks Leucovorin 200 mg/m2, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks
FOLFOX6 cycles 4 onwardsDrug
Also called Eloxatin, Folinic acid, 5-FU
Oxaliplatin 85 mg/m2 given, IV infusion, q 2 weeks Leucovorin 200 mg/m2 given, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks
Bevacizumab cycles 3 onwardsDrug
Also called Avastin
Bevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity and safety
Measured: from study entry until 28 days after last cycle of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Why it stopped: Withdrawn by the study sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dennis Carter, MD, Principal investigator, Rocky Mountain Cancer CenterCharlie Nutting, DO, Principal investigator, Skye Ridge Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735241
- Sponsor's protocol ID
- STX0207
- Acronym
- FAST
- Status last verified
- May 2015
- First submitted
- 13 Aug 2008
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of FOLFOX6 Plus Sir-Spheres® Microspheres (Chemo-radiotherapy) in Combination With Bevacizumab (Avastin) as a First Line Treatment in Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00735241
- Acronym / sponsor ID
- FAST / STX0207
- Conditions
- Colorectal Carcinoma, Liver Metastases
- Keywords
- colon cancer, colorectal cancer, liver metastases, SIR-Spheres Microspheres, yttrium-90, FOLFOX, Bevacizumab, chemo-radiation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn by the study sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sirtex MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 14 Aug 2008 (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.
This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), in combination with the biologic therapy Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from colorectal carcinoma in whom surgical resection is not feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed adenocarcinoma of the colon or rectum.
- Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent.
- ECOG performance status 0 - 1.
- Adequate hematological, renal and hepatic function.
Key exclusion criteria (4 listed)
- Evidence of ascites, cirrhosis, portal hypertension, main portal vein tumor involvement or thrombosis as determined by clinical or radiologic assessment.
- Any extra-hepatic metastases other than metastases in the lungs and/or bones and/or abdominal or hilar lymph nodes. Central nervous system (CNS) metastases are not allowed.
- Previous radiotherapy delivered to the upper abdomen.
- Peripheral neuropathy > grade 1 (NCI-CTCv3).
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 |
|---|---|---|
| SIR-Spheres microspheresSIR-Spheres yttrium-90 microspheres | Device | – |
| FOLFOX6 cycles 1-3Also: Eloxatin, Folinic acid, 5-FUOxaliplatin 60 mg/m2, IV infusion, q 2 weeks Leucovorin 200 mg/m2, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks | Drug | – |
| FOLFOX6 cycles 4 onwardsAlso: Eloxatin, Folinic acid, 5-FUOxaliplatin 85 mg/m2 given, IV infusion, q 2 weeks Leucovorin 200 mg/m2 given, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks | Drug | – |
| Bevacizumab cycles 3 onwardsAlso: AvastinBevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy | Drug | – |
Primary outcome
Toxicity and safety
Time frame: from study entry until 28 days after last cycle of chemotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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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.
Dennis Carter, MD principal investigator
Rocky Mountain Cancer Center
Charlie Nutting, DO principal investigator
Skye Ridge Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SIR-Spheres microspheres, FOLFOX6 cycles 1-3 and FOLFOX6 cycles 4 onwards in people with Colorectal Carcinoma and Liver Metastases, run by Sirtex Medical at 3 sites in United States.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 combined 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Toxicity and safety (time frame: from study entry until 28 days after last cycle of chemotherapy). 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 22 May 2015.