GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer

Tracking Information
First Submitted Date ICMJE	May 12, 2005
First Posted Date ICMJE	May 13, 2005
Last Update Posted Date	March 6, 2012
Study Start Date ICMJE	May 2005
Actual Primary Completion Date	June 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 5, 2012)	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
Original Primary Outcome Measures ICMJE; (submitted: June 23, 2005)	frequency of objective complete or partial tumor response, as characterized by Response Evaluation Criteria in Solid Tumors (RECIST) criteria; frequency of stable and progressive disease
Change History	Complete list of historical versions of study NCT00110721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 5, 2012)	safety of GM-CT-01 plus 5-FU [ Time Frame: 20 patients completed treatment ]; Frequency and type of AE/SAE and ancillary clinical indicators including Eastern Cooperative Oncology Group (ECOG) performance and quality of life.
Original Secondary Outcome Measures ICMJE; (submitted: June 23, 2005)	safety of DAVANAT plus 5-FU; ancillary clinical indicators including Eastern Cooperative Oncology Group (ECOG) performance, carcinoembryonic antigen (CEA) levels, and quality of life
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer
Official Title ICMJE	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
Brief 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. 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 Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Colorectal Cancer
Intervention ICMJE	Drug: GM-CT-01 plus 5-Fluorouracil; 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.; Other Name: DAVANAT
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: March 5, 2012)	20
Original Enrollment ICMJE; (submitted: June 23, 2005)	33
Actual Study Completion Date	February 2008
Actual Primary Completion Date	June 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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).; 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 Exclusion Criteria: 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.; 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Israel, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00110721
Other Study ID Numbers ICMJE	DAVFU-003
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Galectin Therapeutics Inc.
Study Sponsor ICMJE	Galectin Therapeutics Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Galectin Therapeutics Inc.
Verification Date	March 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP