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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00310076 |
RATIONALE: Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving thalidomide after surgery and chemotherapy may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well thalidomide works in treating patients who have undergone surgery and received chemotherapy directly into the abdomen by hyperthermic perfusion for cancer that has spread throughout the abdomen due to colorectal cancer or appendix cancer .
Condition | Intervention | Phase |
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Carcinoma of the Appendix Colorectal Cancer |
Drug: thalidomide Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer |
Estimated Enrollment: | 43 |
Study Start Date: | October 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral thalidomide once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 12 months.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer
Underwent cytoreductive surgery and intraperitoneal hyperthermic chemotherapy (IPHC) within the past 12 weeks
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 |
Study Chair: | Perry Shen, MD | Wake Forest University |
Study ID Numbers: | CDR0000466311, CCCWFU-59202, CCCWFU-BG02-406, CELGENE-CCCWFU-59202 |
Study First Received: | March 29, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00310076 History of Changes |
Health Authority: | United States: Federal Government |
carcinoma of the appendix stage II colon cancer stage III colon cancer stage IV colon cancer recurrent colon cancer |
stage II rectal cancer stage III rectal cancer stage IV rectal cancer recurrent rectal cancer |
Digestive System Neoplasms Immunologic Factors Thalidomide Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Adjuvants, Immunologic Rectal Neoplasm Intestinal Diseases Angiogenesis Inhibitors Immunosuppressive Agents Rectal Diseases |
Recurrence Intestinal Neoplasms Carcinoma Fever Anti-Bacterial Agents Rectal Cancer Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Thalidomide Immunologic Factors Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Physiological Effects of Drugs Rectal Diseases Anti-Bacterial Agents Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Digestive System Neoplasms Neoplasms by Histologic Type |
Growth Substances Intestinal Diseases Immunosuppressive Agents Angiogenesis Inhibitors Intestinal Neoplasms Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial Leprostatic Agents |