Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer

Sponsor

ARCA Biopharma, Inc. (Industry)

Overall Status

Suspended

CT.gov ID

NCT00443573

Collaborator

(none)

100

Enrollment

Location

Study Details

Study Description

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, subcutaneous rNAPc2 for the second-line treatment of metastatic colorectal carcinoma in combination with contemporary 5-FU-based chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Drug: recombinant nematode anticoagulant protein c2 (rNAPc2)	Phase 1/Phase 2

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2006

Anticipated Primary Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

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) [30 days after study completion]

Secondary Outcome Measures

Safety measured by adverse events [30 days after study completion]
Efficacy measured by new metastasis-free survival by 8 months [8 months]
Survival by 8 months [8 months]
Arterial or venous thrombosis [8 months]
Tumor response rate, as assessed by RECIST criteria [30 days after study completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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