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Home > "C" Clinical Trials Conditions > Colorectal Cancer

Colorectal Cancer



Colorectal Cancer

For Condition: Colorectal Neoplasms
Status: No longer recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 96

Location and Contact Information:

Rocky Mountain Cancer Center
Fort Collins,  Colorado,  80524
United States
 

Hopital Saint Antoine
Paris,  ,  75012
France
 

Carolinas Hematology-Oncology
Charlotte,  North Carolina,  28203
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425
United States
 

Uniklinik Dresden, Medizinische Klinik und Poliklinik I
Dresden,  ,  1307
Germany
 

Columbia University, The Herbert Irving Pavilion
New York City,  New York,  10032
United States
 

St. Vincent's CCC
New York City,  New York,  10011
United States
 

Karolinska Hospital
Stockholm,  ,  17176
Sweden
 

Oncologic Clinic
Prague,  ,  128 08
Germany
 

UMass Memorial Medical Center, Division of Hematology/Oncology
Worcester,  Massachusetts,  01655
United States
 

University of California, San Francisco
San Francisco,  California,  94115-1705
United States
 

Northwestern University
Chicago,  Illinois,  60611
United States
 

USC Keck School of Medicine US
Los Angeles,  California,  CA
United States
 

Masaryk`s Oncology Institute
Brno,  ,  656 53
Germany
 

Centre of Medical & Pharma Science
Szeged,  ,  H-6720
Hungary
 

UPMC Cancer Pavillion, Divison of Hematology/Oncology
Pittsburgh,  Pennsylvania,  15213
United States
 

UNC-Chapel Hill
Chapel Hill,  North Carolina,  27599-7295
United States
 

Wake Forest University
Winston Salem,  North Carolina,  27157
United States
 

St. Elizabeth Cancer Institute
Bratislava,  ,  812 50
Slovakia
 

Lombardi Cancer Center, Department of Oncology
Washington D.C.,  District of Columbia,  20057
United States
 

National Medical Center, Department of Internal Medicine
Budapest,  ,  H-1135
Hungary
 

Washington University Medical School
St. Louis,  Missouri,  63110
United States
 

Rocky Mountain Cancer Center
Aurora,  Colorado,  80012
United States
 

Clinica Universitaria Navarra, Servicio de Oncología Médica
Pamplona,  ,  31008
Spain
 

Rocky Mountain Cancer Ctr
Denver,  Colorado,  80220
United States
 

Vanderbilt University Medical
Nashville,  Tennessee,  37232
United States
 

Rocky Mountain Cancer Center
Thornton,  Colorado,  80260
United States
 

National Cancer Institute
Bratislava,  ,  830 00
Slovakia
 

Rocky Mountain Cancer Ctr
Littleton,  Colorado,  80120
United States
 

Rocky Mountain Cancer Center
Boulder,  Colorado,  80304
United States
 

Karmanos Cancer Institute
Detroit,  Michigan,  48201
United States
 

Fox Chase/Temple Cancer Center
Philadelphia,  Pennsylvania,  19140
United States
 

Rocky Mountain Cancer Center
Lakewood,  Colorado,  80228
United States
 

Rocky Mountain Cancer Center
Denver,  Colorado,  80218
United States
 

Sahlgrenska Sjukhuset
Göteborg,  ,  416 85
Sweden
 

Univ of Chicago
Chicago,  Illinois,  60637
United States
 

University of Iowa Hospitals
Iowa City,  Iowa,  52242
United States
 

University of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Rocky Mountain Cancer Center
Longmont,  Colorado,  80501
United States
 

New York University School of Medicine
New York City,  New York,  10016
United States
 

Rocky Mountain Cancer Center
Colorado Springs,  Colorado,  80909
United States
 

H. Lee Moffitt Cancer Center
Tampa,  Florida,  33612
United States
 

UAS, Onkologiska kliniken
Uppsala,  ,  751 85
Sweden
 


Additional Information:
Study ID Numbers:
  3128K1-200-WW; 
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063427

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2. A phase II, randomized, open-label, controlled, dose-elevation, multicenter trial of an investigational drug for the prevention of diarrhea associated with Irinotecan/5FU/Leucovorin chemotherapy in patients with previously untreated metastatic colorectal cancer

3. Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal Cancer

4. Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients with Limited Residual Disease After Surgery

5. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies

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