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| Descriptive Information Fields | |||||
| Brief Title † | Thalidomide in Treating Patients Who Have Undergone Surgery and Chemotherapy for Cancer That Has Spread Throughout the Abdomen Due to Colorectal Cancer or Appendix Cancer | ||||
| Official Title † | Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer | ||||
| Brief Summary | 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 . |
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| Detailed Description | 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 |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Time to progression [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Progression-free survival [ Designated as safety issue: No ] Toxicity [ Designated as safety issue: Yes ] |
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| Condition † | Carcinoma of the Appendix Colorectal Cancer |
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| Intervention † | Drug: thalidomide Procedure: adjuvant therapy |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 43 | ||||
| Start Date † | October 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00310076 | ||||
| Organization ID | CDR0000466311 | ||||
| Secondary IDs †† | CCCWFU-59202, CCCWFU-BG02-406, CELGENE-CCCWFU-59202 | ||||
| Study Sponsor † | Wake Forest University | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2006 | ||||
| First Received Date † | March 29, 2006 | ||||
| Last Updated Date | July 23, 2008 | ||||