Trial Outcomes & Findings for Study of Gamma Interfereon in Metastatic Colorectal Carcinoma (NCT NCT00786643)

Last Updated: 2012-03-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)

Results posted on

2012-03-01

Participant Flow

One community oncology research site in the US within the ACORN Network participated in this study. Phase II enrollment started in February 2006 and was closed in December 2008.

Informed consent was obtained from all subjects. All subjects underwent a screening period during which pre-study assessments were completed. Subjects were assigned to a stratum, based on whether or not they had received previous treatment in the metastatic setting, at the time of study enrollment.

Participant milestones

Participant milestones
Measure	Stratum 1 Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.	Stratum 2 Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
Overall Study STARTED	20	28
Overall Study COMPLETED	20	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stratum 1 n=20 Participants Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.	Stratum 2 n=28 Participants Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	19 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age Continuous	62.75 years STANDARD_DEVIATION 12.05 • n=5 Participants	62.32 years STANDARD_DEVIATION 10.13 • n=7 Participants	62.50 years STANDARD_DEVIATION 10.85 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	28 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)

Population: 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.

Outcome measures

Outcome measures
Measure	Stratum 1 n=20 Participants Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.	Stratum 2 n=28 Participants Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
Best Response (BR) Complete response (CR)	0 Participants	0 Participants
Best Response (BR) Partial response (PR)	6 Participants	3 Participants
Best Response (BR) Stable disease (SD)	7 Participants	15 Participants
Best Response (BR) Progressive disease (PD)	6 Participants	6 Participants
Best Response (BR) Not evaluable (NE)	1 Participants	4 Participants

SECONDARY outcome

Timeframe: After 4 cycles of treatment (approximately 56 days)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Stratum 1 n=20 Participants Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.	Stratum 2 Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
Early Response Rate (RR) (Stratum 1 Only) Complete response (CR)	0 Participants	—
Early Response Rate (RR) (Stratum 1 Only) Partial response (PR)	5 Participants	—
Early Response Rate (RR) (Stratum 1 Only) Stable disease (SD)	7 Participants	—
Early Response Rate (RR) (Stratum 1 Only) Progressive disease (PD)	6 Participants	—
Early Response Rate (RR) (Stratum 1 Only) Not evaluable (NE)	2 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Stratum 1 n=20 Participants Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.	Stratum 2 n=28 Participants Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
Time to Progression	5.5263 Months Interval 3.03 to 6.45	3.9145 Months Interval 3.75 to 7.37

Adverse Events

Stratum 1

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Stratum 2

Serious events: 5 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Vice President of Scientific Affairs

Accelerated Community Oncology Research Network, Inc.

Phone: 901-435-5570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If the Investigator wishes to make a submission for a presentation or publication, the Investigator shall submit all such materials to InterMune at least 60 days prior to the date on which such submission is proposed to be made, and InterMune shall provide timely review of such materials. InterMune may cause the presentation or submission to be delayed for up to 60 additional days if patentable material or proprietary information is identified.
Publication restrictions are in place

Restriction type: OTHER

Measure	Stratum 1 n=20 participants at risk Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.	Stratum 2 n=27 participants at risk Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
Blood and lymphatic system disorders Anemia	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Cardiac disorders Cardiac arrest	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Abdominal pain	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Diarrhoea	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Nausea	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	7.4% 2/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Gastrointestinal disorders Vomiting	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	7.4% 2/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
General disorders Asthenia	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
General disorders Fatigue	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
General disorders Suprapubic pain	5.0% 1/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	0.00% 0/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Infections and infestations Abdominal infection	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Investigations Liver function test abnormal	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Investigations Urine output decreased	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Investigations Weight decreased	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Metabolism and nutrition disorders Dehydration	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Renal and urinary disorders Dysuria	5.0% 1/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	0.00% 0/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Renal and urinary disorders Renal failure acute	0.00% 0/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	3.7% 1/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 1/20 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.	0.00% 0/27 • Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment (approximately every 14 days for up to 310 days). Systematic Assessment - subjects were assessed for adverse events on day 1 of each cycle (every other week) by either the research coordinator, treating physician, or other appropriate sub-investigator.