Clinical trial NCT00110721 (phase 2, status: terminated)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: gm-ct-01 plus 5-fluorouracil
SMILES: FC1=CNC(=O)NC1=O
Reason stopped: 
    study protocol amended to a new treatment regimen: study davfu-006.
  
Eligibility criteria:

        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