This non-randomized, open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with advanced colorectal cancer. Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321. Patients must have been previously treated with at least 1 conventional approved therapeutic regimen and must not be candidates for surgical resection.

A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside of this research trial.

Condition	Treatment or Intervention	Phase
Colorectal Neoplasms	Drug: MAC-321	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

A physician participating in the study will determine eligibility, but if you meet the following criteria, you may qualify for this study:

• Diagnosis of metastatic or relapsed colorectal cancer after treatment with at least 1 prior conventional approved therapeutic regimen but not candidate for surgical resection.
• Recovery from all acute side effects of prior therapies (with the exception of hair loss).
• Adequate bone marrow, liver, and kidney function.

Exclusion Criteria:

• More than 2 prior chemotherapy regimens for relapsed and/or metastatic colorectal cancer. (More than 3 prior treatment regimens if adjuvant therapy is included.)
• Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of beginning study.
• Symptomatic brain metastases.
• Serious health problems such as concurrent serious infections, disabling heart disease, or uncontrolled major seizure disorder.
• History of allergic reactions to docetaxel or paclitaxel.
• Prior exposure to MAC-321.

California
      USC Keck School of Medicine US, Los Angeles,  California,  CA,  United States
      University of California, San Francisco, San Francisco,  California,  94115-1705,  United States
Colorado
      Rocky Mountain Cancer Center, Denver,  Colorado,  80218,  United States
      Rocky Mountain Cancer Center, Aurora,  Colorado,  80012,  United States
      Rocky Mountain Cancer Center, Boulder,  Colorado,  80304,  United States
      Rocky Mountain Cancer Center, Colorado Springs,  Colorado,  80909,  United States
      Rocky Mountain Cancer Ctr, Denver,  Colorado,  80220,  United States
      Rocky Mountain Cancer Center, Lakewood,  Colorado,  80228,  United States
      Rocky Mountain Cancer Ctr, Littleton,  Colorado,  80120,  United States
      Rocky Mountain Cancer Center, Longmont,  Colorado,  80501,  United States
      Rocky Mountain Cancer Center, Fort Collins,  Colorado,  80524,  United States
      Rocky Mountain Cancer Center, Thornton,  Colorado,  80260,  United States
District of Columbia
      Lombardi Cancer Center, Department of Oncology, Washington,  District of Columbia,  20057,  United States
Florida
      H. Lee Moffitt Cancer Center, Tampa,  Florida,  33612,  United States
Illinois
      Univ of Chicago, Chicago,  Illinois,  60637,  United States
      Northwestern University, Chicago,  Illinois,  60611,  United States
Iowa
      University of Iowa Hospitals, Iowa City,  Iowa,  52242,  United States
Massachusetts
      UMass Memorial Medical Center, Division of Hematology/Oncology, Worcester,  Massachusetts,  01655,  United States
Michigan
      Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
Missouri
      Washington University Medical School, St. Louis,  Missouri,  63110,  United States
New York
      St. Vincent's CCC, New York,  New York,  10011,  United States
      Columbia University, The Herbert Irving Pavilion, New York,  New York,  10032,  United States
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States
      New York University School of Medicine, New York,  New York,  10016,  United States
North Carolina
      Wake Forest University, Winston Salem,  North Carolina,  27157,  United States
      UNC-Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States
      Carolinas Hematology-Oncology, Charlotte,  North Carolina,  28203,  United States
Pennsylvania
      UPMC Cancer Pavillion, Divison of Hematology/Oncology, Pittsburgh,  Pennsylvania,  15213,  United States
      Fox Chase/Temple Cancer Center, Philadelphia,  Pennsylvania,  19140,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States
Tennessee
      Vanderbilt University Medical, Nashville,  Tennessee,  37232,  United States

Study ID Numbers:  3128K1-200-WW
Record last reviewed:  January 2005
Last Updated:  January 27, 2005
Record first received:  June 26, 2003
ClinicalTrials.gov Identifier:  NCT00063427
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08