A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or Capecitabine

This study has been completed.
Sponsor:
Collaborator:
US Oncology Research
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00390676
First received: October 18, 2006
Last updated: December 27, 2010
Last verified: December 2010
  Purpose

N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 and carboplatin or ADH-1 and docetaxel or ADH-1 and capecitabine in subjects with specific incurable, solid tumors with a protein biomarker called N-cadherin.


Condition Intervention Phase
Neoplasms
Drug: ADH -1 and carboplatin
Drug: ADH -1 and docetaxel
Drug: ADH -1 and capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Dose-Escalation Study to Investigate the Safety and Tolerability of ADH-1 in Combination With 1) Carboplatin or 2) Docetaxel or 3) Capecitabine in Subjects With N-Cadherin Positive, Advanced Solid Tumors (Adherex Protocol Number AHX-01-006)

Resource links provided by NLM:


Further study details as provided by Adherex Technologies, Inc.:

Study Start Date: November 2006
Study Completion Date: November 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Signed written informed consent
  • Male and female patients > or = 18 years of age with a solid tumor(s) that is locally advanced or metastatic for which single agent carboplatin, or docetaxel or capecitabine would be appropriate
  • Measurable disease
  • Immunohistochemical evidence of N-cadherin expression in tumor tissue
  • Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG

Exclusion criteria:

  • Receipt of ADH-1 prior to this clinical study
  • Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry
  • History of spinal cord compression, or history of primary brain tumor(s) or brain metastases (known or suspected) unless any lesions have completely resolved following appropriate treatment and there has been no recurrence for at least 6 months
  • History of tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry
  • Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
  • Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390676

Locations
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Florida
Cancer Centers of Florida
Ocoee, Florida, United States, 34761
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
United States, New York
New York Oncology Hematology P.C.
Albany, New York, United States, 12208
United States, Ohio
Dayton Oncology & Hematology, P.A
Kettering, Ohio, United States, 45409
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Oncology, PA
Dallas, Texas, United States, 75246
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Northwest Cancer Specialists - Vancouver Cancer Center
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
Adherex Technologies, Inc.
US Oncology Research
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Study Manager, Adherex Technologies
ClinicalTrials.gov Identifier: NCT00390676     History of Changes
Other Study ID Numbers: AHX-01-006
Study First Received: October 18, 2006
Last Updated: December 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Adherex Technologies, Inc.:
cancer
tumors
anticarcinogenic agents
antineoplastic agents
cadherins
solid tumors

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Capecitabine
Antineoplastic Agents
Carboplatin
Anticarcinogenic Agents
Therapeutic Uses
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014