Colorectal CancerPhase 2CC6NCT02118064
Phase II Study to Evaluate G17DT in Combination With Irinotecan in Patients With Colorectal Carcinoma
A Phase 2 study testing G17DT-Irinotecan in people with Colorectal Cancer, run by Cancer Advances Inc..
Trial 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. 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?
- G17DT-Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Dec 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 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:
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- 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
Who cannot join
- 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
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- 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
About this study
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.
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.
- Conditions
- Colorectal Cancer
- Being tested
- G17DT-Irinotecan
- Keywords
- G17DT, irinotecan, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G17DT-IrinotecanBiological
500µg dose of G17DT intramuscular injection in combination with 125 mg/m^2 intravenous infusion of Irinotecan over 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| G17DT-Irinotecan | Experimental | 500µg dose of G17DT intramuscular injection in combination with 125 mg/m^2 intravenous infusion of Irinotecan over 90 minutes. Receives: Biological: G17DT-Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Evaluate the effect of G17DT-Irinotecan combination therapy on tumor response assessed by magnetic resonance imaging or computed tomography.
Measured: up to 12 months
Survival time
The vital status of patients was monitored until death or end of the study.
Measured: up to 12 months
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMar 2001
- Primary completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Advances Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118064
- Sponsor's protocol ID
- CC6
- Acronym
- CC6
- Status last verified
- Jan 2014
- First submitted
- 16 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02118064
- Acronym / sponsor ID
- CC6 / CC6
- Conditions
- Colorectal Cancer
- Keywords
- G17DT, irinotecan, Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Cancer Advances Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- Dec 2002 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G17DT-Irinotecan | Experimental | Biological: G17DT-Irinotecan500µg dose of G17DT intramuscular injection in combination with 125 mg/m^2 intravenous infusion of Irinotecan over 90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| G17DT-Irinotecan500µg dose of G17DT intramuscular injection in combination with 125 mg/m^2 intravenous infusion of Irinotecan over 90 minutes. | Biological | G17DT-Irinotecan |
Primary outcome
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.
Survival time
Time frame: up to 12 months
The vital status of patients was monitored until death or end of the study.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G17DT-Irinotecan in people with Colorectal Cancer, run by Cancer Advances Inc..
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 17 inclusion and 18 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tumor response (time frame: up to 12 months). The study lists 3 primary outcomes in all. 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 21 Apr 2014.