Colorectal CancerPhase 2GFLNCT00786643
Study of Gamma Interfereon in Metastatic Colorectal Carcinoma
A Phase 2 study testing 5-Fluorouracil, Leucovorin (LV) and Gamma-Interferon-1b (IFN-γ) in people with Colorectal Cancer, run by Accelerated Community Oncology Research Network at 1 site in United States.
Trial summary
The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- 5-Fluorouracil, Leucovorin (LV) and Gamma-Interferon-1b (IFN-γ)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Mar 2010
- 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
- Metastatic colorectal cancer, histologically or cytologically confirmed
- Age 18 or greater
- Adequate hematologic function (ANC > 1500, hemoglobin > 10 g/dl, platelet count > 100,000)
- Adequate hepatic parameters (bilirubin < 2.0, Alk. Phos < 5 times normal, ALT < 5 times normal)
- Adequate renal function (creatinine < 2.0)
- Performance status ECOG 0-2
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- 0-2 prior lines of chemotherapy for metastatic colorectal cancer are allowed. Prior 5-FU/LV or capecitabine allowed either in the adjuvant setting, or in the metastatic setting or both.
- Absence of other serious concurrent medical illnesses
- Evaluable or measurable disease for phase I; measurable disease only for phase II
Who cannot join
- Histologies other than adenocarcinoma
- Previous grade 4 toxicity to 5-FU +/- LV or capecitabine
- Uncontrolled brain metastases
- Chronic diarrhea (greater than five bowel movements per day)
- Previous chemotherapy or radiation therapy less than 4 weeks prior to study day 1 (less than 6 weeks for chemotherapy with Mitomycin or nitrosoureas)
- Major surgery within 2 weeks before study entry
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- Known allergic sensitivity to leucovorin
- Prior exposure to IFN-γ
- Previous hematopoietic growth factor (e.g. epoetin alfa or darbepoietin less than 2 weeks prior to study day 1)
- Pregnancy or breast feeding. Women of child-bearing potential must have a negative pregnancy test before the first dose.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
- Inability to provide written and informed consent
- Uncontrolled hypertension
- History of deep venous thrombosis or CVA
- Prior exposure to bevacizumab
- Proteinuria > 500 mg/24 hr
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Gamma Interferon (IFN-γ) Added to Bolus + Infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) +/- Bevacizumab (BV) in Metastatic Colorectal Carcinoma
The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab.
- Conditions
- Colorectal Cancer
- Being tested
- 5-Fluorouracil, Leucovorin (LV), Gamma-Interferon-1b (IFN-γ), Bevacizumab
- Keywords
- Gamma Interferon, 5-FU, LV
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FluorouracilDrug
Also called Fluororacil, 5-FU
5-FU bolus was administered at 400mg/m^2 on day 1 and day 2 of each cycle. 5-FU at 600 mg/m^2 infusion was administered over 22 hours on day 1 and day 2 of each cycle.
Leucovorin (LV)Drug
Also called leucovorin calcium, folinic acid
Leucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle.
Gamma-Interferon-1b (IFN-γ)Drug
Also called Gamma-Interferon-1b, Gamma-Interferon, Actimmune
Gamma-Interferon 150 mcg/m^2 was administered by subcutaneous injection on day 1 of each cycle immediately before treatment with 5-FU and LV, and on day 3 of each cycle immediately after treatment with 5-FU and LV.
BevacizumabDrug
Also called Avastin
Bevacizumab 5mg/kg was only added to the treatment regimen of patients in stratum 1 who demonstrated stable disease on imaging repeated prior to the 5th cycle of treatment. Bavacizumab was administered on day 4 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1 | Experimental | Patients in stratum 1 have not received prior chemotherapy in the metastatic setting. Receives: Drug: 5-Fluorouracil; Drug: Leucovorin (LV); Drug: Gamma-Interferon-1b (IFN-γ); Drug: Bevacizumab |
| Stratum 2 | Experimental | Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting. Receives: Drug: 5-Fluorouracil; Drug: Leucovorin (LV); Drug: Gamma-Interferon-1b (IFN-γ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Response (BR)
BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions.
Measured: After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)
Secondary outcomes (2)
Early Response Rate (RR) (Stratum 1 Only)
Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions.
Measured: After 4 cycles of treatment (approximately 56 days)
Time to Progression
Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline.
Measured: From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startFeb 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accelerated Community Oncology Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- InterMune
- Responsible party
- Sponsor
- Investigators
- Lee Schwartzberg, MD, Study chair, Vector Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786643
- Sponsor's protocol ID
- WITMMCC0301
- Acronym
- GFL
- Status last verified
- Feb 2012
- First submitted
- 3 Nov 2008
- Last updated
- 1 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gamma Interferon (IFN-γ) Added to Bolus + Infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) +/- Bevacizumab (BV) in Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00786643
- Acronym / sponsor ID
- GFL / WITMMCC0301
- Conditions
- Colorectal Cancer
- Keywords
- Gamma Interferon, 5-FU, LV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Accelerated Community Oncology Research NetworkUniversity, hospital or other
- Collaborators
- InterMune
- Study start
- Feb 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Posted 22 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratum 1 | Experimental | Drug: 5-Fluorouracil, Drug: Leucovorin (LV), Drug: Gamma-Interferon-1b (IFN-γ), Drug: BevacizumabPatients in stratum 1 have not received prior chemotherapy in the metastatic setting. |
| Stratum 2 | Experimental | Drug: 5-Fluorouracil, Drug: Leucovorin (LV), Drug: Gamma-Interferon-1b (IFN-γ)Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Metastatic colorectal cancer, histologically or cytologically confirmed
- Age 18 or greater
- Adequate hematologic function (ANC > 1500, hemoglobin > 10 g/dl, platelet count > 100,000)
- Adequate hepatic parameters (bilirubin < 2.0, Alk. Phos < 5 times normal, ALT < 5 times normal)
- Adequate renal function (creatinine < 2.0)
Key exclusion criteria (16 listed)
- Histologies other than adenocarcinoma
- Previous grade 4 toxicity to 5-FU +/- LV or capecitabine
- Uncontrolled brain metastases
- Chronic diarrhea (greater than five bowel movements per day)
- Previous chemotherapy or radiation therapy less than 4 weeks prior to study day 1 (less than 6 weeks for chemotherapy with Mitomycin or nitrosoureas)
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-FluorouracilAlso: Fluororacil, 5-FU5-FU bolus was administered at 400mg/m^2 on day 1 and day 2 of each cycle. 5-FU at 600 mg/m^2 infusion was administered over 22 hours on day 1 and day 2 of each cycle. | Drug | Stratum 1, Stratum 2 |
| Leucovorin (LV)Also: leucovorin calcium, folinic acidLeucovorin 200mg/m^2 was administered over 2 hours on day 1 and day 2 of each cycle. | Drug | Stratum 1, Stratum 2 |
| Gamma-Interferon-1b (IFN-γ)Also: Gamma-Interferon-1b, Gamma-Interferon, ActimmuneGamma-Interferon 150 mcg/m^2 was administered by subcutaneous injection on day 1 of each cycle immediately before treatment with 5-FU and LV, and on day 3 of each cycle immediately after treatment with 5-FU and LV. | Drug | Stratum 1, Stratum 2 |
| BevacizumabAlso: AvastinBevacizumab 5mg/kg was only added to the treatment regimen of patients in stratum 1 who demonstrated stable disease on imaging repeated prior to the 5th cycle of treatment. Bavacizumab was administered on day 4 of each cycle. | Drug | Stratum 1 |
Primary outcome
Best Response (BR)
Time frame: After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)
BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions.
2 secondary outcomes
Early Response Rate (RR) (Stratum 1 Only)
Time frame: After 4 cycles of treatment (approximately 56 days)
Time to Progression
Time frame: From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lee Schwartzberg, MD study chair
Vector Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-Fluorouracil, Leucovorin (LV) and Gamma-Interferon-1b (IFN-γ) in people with Colorectal Cancer, run by Accelerated Community Oncology Research Network at 1 site 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 9 inclusion and 16 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 1 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 22 Feb 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?
Best Response (BR) (time frame: After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)). 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 1 Mar 2012.