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Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Colon Cancer

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Trial Information

Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2

Cytotoxic chemotherapy combining 5-fluorouracil and leucovorin with irinotecan (FOLFIRI) or
oxaliplatin (FOLFOX) or, more recently, treatment with XELOX (Roche) (capecitabine +
oxaliplatin) has been the main approach for the treatment of metastatic colorectal carcinoma
(mCRC), but with the advent of targeted therapies, biologic treatments are becoming an area
of intense interest. Tissue factor (TF) is a transmembrane glycoprotein expressed by upwards
of 85% of mCRCs.

Inclusion Criteria

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Safety measured by major hemorrhage (NCI CTCAE v3.0 grade 3 or greater), during and up to 30 days after completion of study drug administration or, if treatment is ongoing, by 8 months after study enrollment (Stage I) or randomization (Stage II)

Outcome Time Frame:

30 days after study completion

Safety Issue:


Principal Investigator

Ted Love, MD

Investigator Role:

Study Chair

Investigator Affiliation:

ARCA Biopharma, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

Related Keywords:

  • Colon Cancer
  • metastatic colorectal carcinoma (mCRC)
  • colorectal carcinoma (CRC)
  • tissue factor
  • factor VIIa
  • rNAPc2
  • adenocarcinoma
  • targeted therapy
  • coagulation-dependent
  • 5-FU-based chemotherapy
  • leucovorin
  • Colonic Neoplasms
  • Colorectal Neoplasms



LAC/USC Medical CenterLos Angeles, California  90033