Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

frequency of objective complete or partial tumor response

Outcome Description:

Tumor response as characterized by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Outcome Time Frame:

20 patients completed treatment

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

February 2008

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • 5-fluorouracil
  • Colorectal Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Ochsner Clinic Foundation New Orleans, Louisiana  70121
Medical Oncology and Hematology Waterbury, Connecticut  06708
Hematology-Oncology Associates of the Treasure Coast Port St. Lucie, Florida  34952