Status:
SUSPENDED
Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer
Lead Sponsor:
ARCA Biopharma, Inc.
Conditions:
Colon Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multicenter, two-stage trial with the goal of evaluating up to 100 subjects. This trial will be performed to initiate identification of a safe and effective dose of twice-weekly, subcutaneou...
Detailed Description
Cytotoxic chemotherapy combining 5-fluorouracil and leucovorin with irinotecan (FOLFIRI) or oxaliplatin (FOLFOX) or, more recently, treatment with XELOX (Roche) (capecitabine + oxaliplatin) has been t...
Eligibility Criteria
Inclusion
- Tissue diagnosis of adenocarcinoma of the colon or rectum
- Documented metastatic disease with at least one measurable lesion by RECIST criteria
- Previously treated with 5-FU-based chemotherapy in the form of FOLFIRI, FOLFOX, or XELOX plus bevacizumab as first-line chemotherapy and have recorded progressive disease during treatment or after discontinuation of treatment, when discontinuation of treatment occurred less than 6 months before enrollment (Stage I) or randomization (Stage II)
- Estimated life expectancy of at least 6 months
- Age 18 to 75 years
- Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before enrollment
- No other active malignancy for which the subject is currently receiving treatment (other than mCRC)
- No ongoing therapy with or need for parenteral and oral antithrombotics including anticoagulants and anti-platelet agents (including aspirin) and thrombolytics
- No contraindication to systemic anticoagulation
- No contraindication to modified FOLFOX6 or FOLFIRI combination chemotherapy
- No receipt of any investigational compound within 28 days of enrollment
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00443573
Start Date
December 1 2006
Last Update
May 7 2008
Active Locations (1)
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1
LAC/USC Medical Center
Los Angeles, California, United States, 90033