Back to resultsPhase II Study to Evaluate G17DT in Combination With Irinotecan in Patients With Colorectal Carcinoma (CC6)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
G17DT-Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring G17DT, irinotecan, Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Have histologically confirmed cancer of the colon or rectum or both and objective evidence of distant metastases
- Have measurable disease
- Have previously been treated with an irinotecan based chemotherapy
- Have progressive metastatic disease after an irinotecan containing chemotherapy regimen (alone or in combination) for metastatic colorectal cancer
- Be at least 18 years of age
Have laboratory data as specified below:
- Aspartate aminotransferase (AST) and ALT less than 2.5 times upper limit of normal
- Bilirubin less than 1.5 mg/dL (SI units, 25.65 mol/L)
- Creatinine less than 1.5 mg/dL (SI units, 132 mol/L)
- White blood cell (WBC) count greater than 3,000/mm3
- Platelets greater than 100,000/mm3
- Hemoglobin more than 9.5 g/dL (SI units, 5.9 mol/L)
- International normalized ratio of prothrombin time less than 1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits
- Have a life expectancy of at least 3 months
- Have a KPS score of 70 or greater
- Use contraceptive methods, if sexually active
- Have the ability to understand the requirements of the study, to provide written informed consent, agree to abide by the study restrictions, and agree to return for the required assessments
Exclusion Criteria:
- Be pregnant or nursing
- Have only symptomatic locally recurrent colorectal cancer
- Have had any active cancer in addition to metastatic colorectal cancer within the last 5 years except curatively treated nonmelanomatous skin cancer
- Have received any prior anticancer immunotherapy
- Have central nervous system metastasis, whether treated or not
- Have bone metastases as sole manifestation of metastatic colorectal cancer
- Have received chemotherapy within the previous 21 days
- Have had major surgery within 21 days
- Have immunodeficiency (primary or acquired)
- Have undergone bone marrow transplantation within the last year
- Require chronic administration of corticosteroids; inhaled corticosteroids for asthma and chronic obstructive pulmonary disease are allowed
- Use in the past 30 days or concomitant use of immunosuppressants, including systemic (i.e., oral or injected) corticosteroids
- Have participated in any clinical trial involving conventional or investigational drugs or devices within 21 days before G17DT irinotecan administration
- Have contraindication to irinotecan based therapy
- Have hypersensitivity to diphtheria toxoid
- Use in the past 14 days or chronic concomitant use of proton pump inhibitors
- Have uncontrolled serious cardiovascular or metabolic disease or any other uncontrolled serious medical or psychiatric illness
- Have any condition that is likely to detrimentally affect regular follow up
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
G17DT-Irinotecan
Arm Description
500µg dose of G17DT intramuscular injection in combination with 125 mg/m^2 intravenous infusion of Irinotecan over 90 minutes.
Outcomes
Primary Outcome Measures
Tumor response
Evaluate the effect of G17DT-Irinotecan combination therapy on tumor response assessed by magnetic resonance imaging or computed tomography.
Survival time
The vital status of patients was monitored until death or end of the study.
Number of Patients with Serious and Non-Serious Adverse Events
Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02118064
Brief Title
Phase II Study to Evaluate G17DT in Combination With Irinotecan in Patients With Colorectal Carcinoma
Acronym
CC6
Official Title
A Multinational, Multicenter, Open-label, Single-arm, Phase II Study of G17DT Immunogen in Combination With Irinotecan in Metastatic Colorectal Carcinoma Refractory to Previous Irinotecan-based Chemotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Advances Inc.
4. Oversight
5. Study Description
Brief Summary
This study was designed to evaluate the ability for G17DT to slow or arrest tumor growth in patients with refractory colon cancer who had been previously treated with an Irinotecan-based chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
G17DT, irinotecan, Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G17DT-Irinotecan
Arm Type
Experimental
Arm Description
500µg dose of G17DT intramuscular injection in combination with 125 mg/m^2 intravenous infusion of Irinotecan over 90 minutes.
Intervention Type
Biological
Intervention Name(s)
G17DT-Irinotecan
Intervention Description
500µg dose of G17DT intramuscular injection in combination with 125 mg/m^2 intravenous infusion of Irinotecan over 90 minutes.
Primary Outcome Measure Information:
Title
Tumor response
Description
Evaluate the effect of G17DT-Irinotecan combination therapy on tumor response assessed by magnetic resonance imaging or computed tomography.
Time Frame
up to 12 months
Title
Survival time
Description
The vital status of patients was monitored until death or end of the study.
Time Frame
up to 12 months
Title
Number of Patients with Serious and Non-Serious Adverse Events
Description
Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have histologically confirmed cancer of the colon or rectum or both and objective evidence of distant metastases
Have measurable disease
Have previously been treated with an irinotecan based chemotherapy
Have progressive metastatic disease after an irinotecan containing chemotherapy regimen (alone or in combination) for metastatic colorectal cancer
Be at least 18 years of age
Have laboratory data as specified below:
Aspartate aminotransferase (AST) and ALT less than 2.5 times upper limit of normal
Bilirubin less than 1.5 mg/dL (SI units, 25.65 mol/L)
Creatinine less than 1.5 mg/dL (SI units, 132 mol/L)
White blood cell (WBC) count greater than 3,000/mm3
Platelets greater than 100,000/mm3
Hemoglobin more than 9.5 g/dL (SI units, 5.9 mol/L)
International normalized ratio of prothrombin time less than 1.2, and activated partial thromboplastin time no more than 5 seconds above normal limits
Have a life expectancy of at least 3 months
Have a KPS score of 70 or greater
Use contraceptive methods, if sexually active
Have the ability to understand the requirements of the study, to provide written informed consent, agree to abide by the study restrictions, and agree to return for the required assessments
Exclusion Criteria:
Be pregnant or nursing
Have only symptomatic locally recurrent colorectal cancer
Have had any active cancer in addition to metastatic colorectal cancer within the last 5 years except curatively treated nonmelanomatous skin cancer
Have received any prior anticancer immunotherapy
Have central nervous system metastasis, whether treated or not
Have bone metastases as sole manifestation of metastatic colorectal cancer
Have received chemotherapy within the previous 21 days
Have had major surgery within 21 days
Have immunodeficiency (primary or acquired)
Have undergone bone marrow transplantation within the last year
Require chronic administration of corticosteroids; inhaled corticosteroids for asthma and chronic obstructive pulmonary disease are allowed
Use in the past 30 days or concomitant use of immunosuppressants, including systemic (i.e., oral or injected) corticosteroids
Have participated in any clinical trial involving conventional or investigational drugs or devices within 21 days before G17DT irinotecan administration
Have contraindication to irinotecan based therapy
Have hypersensitivity to diphtheria toxoid
Use in the past 14 days or chronic concomitant use of proton pump inhibitors
Have uncontrolled serious cardiovascular or metabolic disease or any other uncontrolled serious medical or psychiatric illness
Have any condition that is likely to detrimentally affect regular follow up
12. IPD Sharing Statement
Learn more about this trial
Phase II Study to Evaluate G17DT in Combination With Irinotecan in Patients With Colorectal Carcinoma
We'll reach out to this number within 24 hrs