Colorectal CancerPhase 1/2NCT00291785
Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
A Phase 1/2 study testing CT-2106, Folinic acid and 5-FU (fluorouracil) in people with Colorectal Cancer, run by CTI BioPharma at 2 sites in Italy.
Trial summary
CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. 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?
- CT-2106, Folinic acid and 5-FU (fluorouracil)
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2004to Sep 2008
- Phase
- Phase 1/2
- 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
- Histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-FU/FA
- At least one measurable lesion according to RECIST criteria for both Phase I and II
- ECOG performance status 0 or 1
- Adequate hematologic, renal and hepatic function
- Wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy
Who cannot join
- Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
- Pregnant or lactating patients
- Prior treatment with camptothecins
- Presence or history of CNS metastasis or carcinomatous leptomeningitis
- Current active infection per investigator assessment
- Unresolved bowel obstruction or partial obstruction, uncontrolled Crohn's disease or ulcerative colitis
- Current history of chronic diarrhea greater than or equal to grade 1 (CTCAE version 3)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Policlinico Universitario "A.Gemelli"
Rome
Istituto Clinico Humanitas
Rozzano
About this study
Official title: Phase I/II Study of CT-2106 in Combination With Infusional 5-fluorouracil/Folinic Acid (5-FU/FA)(de Gramont Schedule) as Second Line in Patients With Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen
CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- CT-2106, Folinic acid, 5-FU (fluorouracil)
- Keywords
- colorectal cancer, camptothecin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-2106Drug
CT-2106 as 10 minute infusion on days 1, 15 \& 29 of each 42-day cycle
Folinic acidDrug
Folinic acid 200 mg IV 1 hour after CT-2106 infusion on days 1, 2, 15, 16, 29 and 30
5-FU (fluorouracil)Drug
5-FU following CT-2106 and folinic acid infusions @ 400 mg/m² IV bolus then 5-FU 600 mg/m² as a 22 hour IV infusion on Days 1, 2, 15, 16, 29, and 30.
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity
Measured: Each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startJan 2004
- Primary completionAug 2007
- Study completionSep 2008
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barone C., M.D., Principal investigator, Policlinico Universitario "A.Gemelli"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291785
- Sponsor's protocol ID
- CAM201
- Status last verified
- Jun 2011
- First submitted
- 14 Feb 2006
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of CT-2106 in Combination With Infusional 5-fluorouracil/Folinic Acid (5-FU/FA)(de Gramont Schedule) as Second Line in Patients With Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen
- ClinicalTrials.gov ID
- NCT00291785
- Acronym / sponsor ID
- CAM201
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, camptothecin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 15 Feb 2006 (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.
CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-FU/FA
- At least one measurable lesion according to RECIST criteria for both Phase I and II
- ECOG performance status 0 or 1
- Adequate hematologic, renal and hepatic function
- Wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy
Key exclusion criteria (7 listed)
- Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
- Pregnant or lactating patients
- Prior treatment with camptothecins
- Presence or history of CNS metastasis or carcinomatous leptomeningitis
- Current active infection per investigator assessment
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 |
|---|---|---|
| CT-2106CT-2106 as 10 minute infusion on days 1, 15 \& 29 of each 42-day cycle | Drug | – |
| Folinic acidFolinic acid 200 mg IV 1 hour after CT-2106 infusion on days 1, 2, 15, 16, 29 and 30 | Drug | – |
| 5-FU (fluorouracil)5-FU following CT-2106 and folinic acid infusions @ 400 mg/m² IV bolus then 5-FU 600 mg/m² as a 22 hour IV infusion on Days 1, 2, 15, 16, 29, and 30. | Drug | – |
Primary outcome
Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity
Time frame: Each cycle
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 8 Jun 2011.
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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.
Barone C., M.D. principal investigator
Policlinico Universitario "A.Gemelli"
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CT-2106, Folinic acid and 5-FU (fluorouracil) in people with Colorectal Cancer, run by CTI BioPharma at 2 sites in Italy.
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 5 inclusion and 7 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity (time frame: Each cycle). 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 8 Jun 2011.