- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02118064
Phase II Study to Evaluate G17DT in Combination With Irinotecan in Patients With Colorectal Carcinoma (CC6)
April 17, 2014 updated by: Cancer Advances Inc.
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.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
161
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: G17DT-Irinotecan
500µg dose of G17DT intramuscular injection in combination with 125 mg/m^2 intravenous infusion of Irinotecan over 90 minutes.
|
500µg dose of G17DT intramuscular injection in combination with 125 mg/m^2 intravenous infusion of Irinotecan over 90 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response
Time Frame: up to 12 months
|
Evaluate the effect of G17DT-Irinotecan combination therapy on tumor response assessed by magnetic resonance imaging or computed tomography.
|
up to 12 months
|
Survival time
Time Frame: up to 12 months
|
The vital status of patients was monitored until death or end of the study.
|
up to 12 months
|
Number of Patients with Serious and Non-Serious Adverse Events
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2001
Primary Completion (Actual)
December 1, 2002
Study Registration Dates
First Submitted
April 16, 2014
First Submitted That Met QC Criteria
April 17, 2014
First Posted (Estimate)
April 21, 2014
Study Record Updates
Last Update Posted (Estimate)
April 21, 2014
Last Update Submitted That Met QC Criteria
April 17, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- CC6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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