Colorectal CancerPhase 2NCT00110721
GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer
A Phase 2 study testing GM-CT-01 plus 5-Fluorouracil in people with Colorectal Cancer, run by Galectin Therapeutics Inc. at 6 sites in 2 countries.
Trial summary
This is a Phase II, multi-center study of GM-CT-01 which has been shown to increase the anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug commonly used in cancer patients. 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?
- GM-CT-01 plus 5-Fluorouracil
- How many people
- 20 participants
- Where
- 6 sitesin 2 countries
- Study dates
- May 2005to Feb 2008
- 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
- 18 years of age or older
- Has a histologically-proven adenocarcinoma of the colon or rectum
- Has documentation of locally advanced or metastatic colorectal cancer not amenable to curative surgery or radiotherapy
- Eligible subjects are those whose unresectable, locally advanced and/or metastatic colorectal cancer has progressed during or after receiving treatment with at least two, but not more than three, lines of therapy that collectively must have included at a minimum all of the following agents: 5-fluorouracil or capecitabine, irinotecan, and oxaliplatin (unless, in the opinion of the investigator, the subject is not able to receive irinotecan and/or oxaliplatin due to medical contraindications, in which case irinotecan and/or oxaliplatin are not required to have been included in the prior lines of therapy). Adjuvant chemotherapy following definitive management of the primary lesion in the colon or rectum is allowed and will not be counted as a line of therapy.
- Has 1 or more measurable lesion(s) ("target lesion[s]") according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
- The same diagnostic imaging method must be used throughout the study to evaluate the lesions; and clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes).
Show all 11Show fewer
- Has an ECOG performance status of 0-2
- Has a life expectancy greater than 3 months
- Has the ability to understand the nature of the study and any hazards of participating in it; to communicate satisfactorily with the Investigator; and to participate in, and comply with, the requirements of the entire study
- A female of childbearing potential must have a negative serum screening test for pregnancy and agree to practice abstinence or use an effective method of contraception
- Has had all aspects of the protocol explained and written informed consent obtained
Who cannot join
- Has central nervous system metastasis
- Has bony metastasis as the sole metastasis
- Has other concomitant or previous malignancy in the past 3 years, except:
- adequately treated in situ carcinoma of the uterine cervix;
- basal or squamous cell carcinoma of the skin; and/or
- melanoma in situ.
Show all 23Show fewer
- Is receiving concomitant anti-neoplastic treatment; has received radiation therapy in the past 3 weeks; has been treated with anti-angiogenesis agents, including bevacizumab, in the past 4 weeks; or has been treated with any other chemotherapeutic agents in the past 4 weeks (6 weeks for mitomycin C and nitrosoureas).
- Has an active infection
- Has congestive heart failure (Class III or IV in the New York Heart Association functional classification system)
- Has a hemoglobin level of < 8.5 gm/dL
- Has a platelet count of < 100,000/mm3
- Has a neutrophil count of < 1,500/mm3
- Has a serum creatinine level of > 2.0 mg/dL
- Has liver aminotransferase and alkaline phosphatase levels that are > 2.5 times the laboratory's upper limit of normal (ULN) in a subject with no liver metastases, and levels that are > 5 times the laboratory's ULN in a subject with liver metastases
- Has a total bilirubin level that is > 2 times the laboratory's ULN
- Has pulmonary DLCO < 60% of predicted
- Has known or clinically suspected infection with human immunodeficiency virus (HIV)
- Has participated within 30 days, or will participate concurrently, in another investigational drug or vaccine study
- Has a history of drug or alcohol dependence in the past 3 years
- Has other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study
- Has known intolerance to 5- FU
- Has previously participated in a GM-CT-01 clinical trial
- Has known hypersensitivity to GM-CT-01 or any of its components
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Hematology-Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Medical Oncology and Hematology
Waterbury, Connecticut, 06708
Israel2 sites
Soroka University Medical Center
Beersheba, 84101
Shaare Zedek Medical Center, Oncology
Jerusalem, 91031
About this study
Official title: A Phase II, Multi-Center, Open-Label Trial to Evaluate the Efficacy and Safety of Intravenous GM-CT-01 in Combination With 5-Fluorouracil When Administered in Monthly Cycles as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer
This is a Phase II, multi-center study of GM-CT-01 which has been shown to increase the anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug commonly used in cancer patients. In this Phase II study, patients with colon cancer which has spread, despite treatment with approved therapies, will receive GM-CT-01 plus 5-FU in monthly cycles for at least 2 cycles or until their disease progresses.
Read the detailed description
A Phase I study of 40 patients showed that GM-CT-01 in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments. The main reason for doing this Phase II study in advanced colorectal cancer patients is to verify the safety observations in the early Phase I study and further evaluate the efficacy of these drugs' combination to stabilize tumors, preventing further growth and potentially shrink tumors.
- Conditions
- Colorectal Cancer
- Being tested
- GM-CT-01 plus 5-Fluorouracil
- Keywords
- colorectal cancer, DAVANAT, 5-fluorouracil
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CT-01 plus 5-FluorouracilDrug
Also called DAVANAT
Single use vials, combined regimen of GM-CT-01 / 5-Fluorouracil (280 mg/m2 /500 mg/m2) given for 4 consecutive days in a 28 day cycle until disease progression.
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of objective complete or partial tumor response
Tumor response as characterized by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Measured: 20 patients completed treatment
frequency of stable disease
Stable disease as measured by CT imaging or carcinoembryonic antigen (CEA) levels
Measured: 20 patients completed treatment
Secondary outcomes (1)
safety of GM-CT-01 plus 5-FU
Frequency and type of AE/SAE and ancillary clinical indicators including Eastern Cooperative Oncology Group (ECOG) performance and quality of life.
Measured: 20 patients completed treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2005 (estimated)
- Study startMay 2005
- Primary completionJun 2007
- Study completionFeb 2008
Why it stopped: Study protocol amended to a new treatment regimen: study DAVFU-006.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galectin Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110721
- Sponsor's protocol ID
- DAVFU-003
- Status last verified
- Mar 2012
- First submitted
- 12 May 2005
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-Center, Open-Label Trial to Evaluate the Efficacy and Safety of Intravenous GM-CT-01 in Combination With 5-Fluorouracil When Administered in Monthly Cycles as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00110721
- Acronym / sponsor ID
- DAVFU-003
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, DAVANAT, 5-fluorouracil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study protocol amended to a new treatment regimen: study DAVFU-006.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Galectin Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 May 2005 (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 is a Phase II, multi-center study of GM-CT-01 which has been shown to increase the anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug commonly used in cancer patients. In this Phase II study, patients with colon cancer which has spread, despite treatment with approved therapies, will receive GM-CT-01 plus 5-FU in monthly cycles for at least 2 cycles or until their disease progresses.
Detailed description
A Phase I study of 40 patients showed that GM-CT-01 in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments. The main reason for doing this Phase II study in advanced colorectal cancer patients is to verify the safety observations in the early Phase I study and further evaluate the efficacy of these drugs' combination to stabilize tumors, preventing further growth and potentially shrink tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (11 listed)
- 18 years of age or older
- Has a histologically-proven adenocarcinoma of the colon or rectum
- Has documentation of locally advanced or metastatic colorectal cancer not amenable to curative surgery or radiotherapy
- Eligible subjects are those whose unresectable, locally advanced and/or metastatic colorectal cancer has progressed during or after receiving treatment with at least two, but not more than three, lines of therapy that collectively must have included at a minimum all of the following agents: 5-fluorouracil or capecitabine, irinotecan, and oxaliplatin (unless, in the opinion of the investigator, the subject is not able to receive irinotecan and/or oxaliplatin due to medical contraindications, in which case irinotecan and/or oxaliplatin are not required to have been included in the prior lines of therapy). Adjuvant chemotherapy following definitive management of the primary lesion in the colon or rectum is allowed and will not be counted as a line of therapy.
- Has 1 or more measurable lesion(s) ("target lesion[s]") according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Key exclusion criteria (23 listed)
- Has central nervous system metastasis
- Has bony metastasis as the sole metastasis
- Has other concomitant or previous malignancy in the past 3 years, except:
- Is receiving concomitant anti-neoplastic treatment; has received radiation therapy in the past 3 weeks; has been treated with anti-angiogenesis agents, including bevacizumab, in the past 4 weeks; or has been treated with any other chemotherapeutic agents in the past 4 weeks (6 weeks for mitomycin C and nitrosoureas).
- Has an active infection
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 |
|---|---|---|
| GM-CT-01 plus 5-FluorouracilAlso: DAVANATSingle use vials, combined regimen of GM-CT-01 / 5-Fluorouracil (280 mg/m2 /500 mg/m2) given for 4 consecutive days in a 28 day cycle until disease progression. | Drug | – |
Primary outcome
frequency of objective complete or partial tumor response
Time frame: 20 patients completed treatment
Tumor response as characterized by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
frequency of stable disease
Time frame: 20 patients completed treatment
Stable disease as measured by CT imaging or carcinoembryonic antigen (CEA) levels
1 secondary outcome
safety of GM-CT-01 plus 5-FU
Time frame: 20 patients completed treatment
Results and safety
The study was stopped early (reason given: Study protocol amended to a new treatment regimen: study DAVFU-006.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
- Sponsor's websiteLink provided by the sponsor.
Related trials for Colorectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-CT-01 plus 5-Fluorouracil in people with Colorectal Cancer, run by Galectin Therapeutics Inc. at 6 sites in 2 countries.
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 11 inclusion and 23 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: stopped early, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Israel. 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 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 was stopped early (reason given: Study protocol amended to a new treatment regimen: study DAVFU-006.). Results are not available in the source record.
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?
frequency of objective complete or partial tumor response (time frame: 20 patients completed treatment). The study lists 2 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 6 Mar 2012.