Clinical trial NCT00443573: Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer
Official title: Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Colon Cancer
Keywords: metastatic colorectal carcinoma (mCRC)
colorectal carcinoma (CRC)
tissue factor
factor VIIa
rNAPc2
adenocarcinoma
targeted therapy
coagulation-dependent
RECIST
5-FU-based chemotherapy
FOLFOX
FOLFIRI
leucovorin
XELOX
Lead sponsor: ARCA Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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 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

Primary outcomes:
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)
timeFrame: 30 days after study completion
Secondary outcomes:
measure: Safety measured by adverse events
timeFrame: 30 days after study completion
measure: Efficacy measured by new metastasis-free survival by 8 months
timeFrame: 8 months
measure: Survival by 8 months
timeFrame: 8 months
measure: Arterial or venous thrombosis
timeFrame: 8 months
measure: Tumor response rate, as assessed by RECIST criteria
timeFrame: 30 days after study completion
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC/USC Medical Center
state: California
Study officials:
affiliation: ARCA Biopharma, Inc.
name: Ted Love, MD
role: STUDY_CHAIR
References: