Trial · NCT00786643
Study of Gamma Interfereon in Metastatic Colorectal Carcinoma
NCT00786643, Phase 2, Completed, Accelerated Community Oncology Research Network; results first posted 2012-02-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Gamma Interfereon in Metastatic Colorectal Carcinoma. Trials, record NCT00786643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00786643
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Gamma Interfereon in Metastatic Colorectal Carcinoma
- NCT number
- NCT00786643
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Accelerated Community Oncology Research Network
- Conditions
- Colorectal Cancer
- Interventions
- 5-Fluorouracil, Leucovorin (LV), Gamma-Interferon-1b (IFN-γ), Bevacizumab
- First posted
- 2008-11-06
- Last updated
- 2012-03-01
- Results first posted
- 2012-02-22
- Limitations and caveats
- Enrollment to stratum 1 was closed early due to difficulty accruing the required number of patients in this stratum.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Response (BR) | 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. |
| Secondary | Early Response Rate (RR) (Stratum 1 Only) | After 4 cycles of treatment (approximately 56 days) | 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. |
| Secondary | Time to Progression | 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 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Response (BR) | After every 4 cycles of treatment (approximately every 56 days for up to about 280 days) | The best response is the best response recorded from the start of treatment until disease progression. Imaging was repeated by same technique after every 4 cycles of treatment. Subjects in both strata were evaluated for this outcome. | Participants | NUMBER |
| SECONDARY | Early Response Rate (RR) (Stratum 1 Only) | After 4 cycles of treatment (approximately 56 days) | Prior to the 5th cycle of treatment, early response rate was evaluated in patients in stratum 1 to assess whether bevacizumab would be added to the GFL treatment regimen. Stratum 1 patients with SD at this time point will have bevacizumab added to the regimen. Subjects in stratum 2 were not evaluated for this outcome. | Participants | NUMBER |
| SECONDARY | Time to Progression | 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 | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Response (BR) | Stratum 1 | Complete response (CR) | 0 | Participants | |
| Best Response (BR) | Stratum 2 | Complete response (CR) | 0 | Participants | |
| Best Response (BR) | Stratum 1 | Partial response (PR) | 6 | Participants | |
| Best Response (BR) | Stratum 2 | Partial response (PR) | 3 | Participants | |
| Best Response (BR) | Stratum 1 | Stable disease (SD) | 7 | Participants | |
| Best Response (BR) | Stratum 2 | Stable disease (SD) | 15 | Participants | |
| Best Response (BR) | Stratum 1 | Progressive disease (PD) | 6 | Participants | |
| Best Response (BR) | Stratum 2 | Progressive disease (PD) | 6 | Participants | |
| Best Response (BR) | Stratum 1 | Not evaluable (NE) | 1 | Participants | |
| Best Response (BR) | Stratum 2 | Not evaluable (NE) | 4 | Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum 1 | 20 | |
| Overall Study | STARTED | Stratum 2 | 28 | |
| Overall Study | COMPLETED | Stratum 1 | 20 | |
| Overall Study | COMPLETED | Stratum 2 | 28 | |
| Overall Study | NOT COMPLETED | Stratum 1 | 0 | |
| Overall Study | NOT COMPLETED | Stratum 2 | 0 |
Source ClinicalTrials.gov
Adverse events292
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Stratum 1 | 4 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Stratum 2 | 3 | 27 | |
| other | Leukopenia | Blood and lymphatic system disorders | Stratum 1 | 0 | 20 | |
| other | Leukopenia | Blood and lymphatic system disorders | Stratum 2 | 1 | 27 | |
| other | Neutropenia | Blood and lymphatic system disorders | Stratum 1 | 6 | 20 | |
| other | Neutropenia | Blood and lymphatic system disorders | Stratum 2 | 12 | 27 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Stratum 1 | 1 | 20 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Stratum 2 | 0 | 27 | |
| other | Atrial fibrillation | Cardiac disorders | Stratum 1 | 1 | 20 | |
| other | Atrial fibrillation | Cardiac disorders | Stratum 2 | 0 | 27 |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum 1 | ||
| Total, all-cause mortality | Stratum 2 | ||
| Total, other adverse events | Stratum 1 | 19 | 20 |
| Total, other adverse events | Stratum 2 | 26 | 27 |
| Total, serious adverse events | Stratum 1 | 2 | 20 |
| Total, serious adverse events | Stratum 2 | 5 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Stratum 1 vs Stratum 2: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00786643
GET https://conductscience.org/api/trials/v1/NCT00786643/events?page=2