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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
This study is ongoing, but not recruiting participants.
First Received: March 29, 2006   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00310076
  Purpose

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
Carcinoma of the Appendix
Colorectal Cancer
Drug: thalidomide
Procedure: adjuvant therapy
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer Fever Surgery
Drug Information available for: Thalidomide
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: October 2002
Detailed Description:

OBJECTIVES:

Primary

  • Determine time to progression from surgery in patients who have undergone cytoreductive surgery and intraperitoneal hyperthermic chemotherapy for peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer treated with adjuvant thalidomide.

Secondary

  • Estimate progression-free survival probability of patients treated with this regimen.
  • Obtain toxicity data for patients receiving long-term oral thalidomide therapy.

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

  Eligibility

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

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

      • Patients with residual disease or no evidence of disease after IPHC are eligible
  • No extra-abdominal disease or parenchymal liver metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Free of infection or postoperative complications
  • Hemoglobin > 8.0 g/dL
  • Absolute neutrophil count > 1,000/mm³
  • Platelet count > 100,000/mm³
  • PTT or PT < 1.5 times normal (except in patients who are receiving therapeutic anticoagulant therapy for non-related medical conditions, such as atrial fibrillation)
  • Bilirubin < 1.5 mg/dL OR direct bilirubin ≤ 1.0 mg/dL (for patients with Gilbert's syndrome)
  • AST/ALT ≤ 2.5 times normal
  • Serum creatinine < 2.0 mg/dL
  • No peripheral neuropathy > grade 1, except localized neuropathy due to a mechanical cause or trauma
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective methods of contraception for 4 months prior to, during, and for 4 months after treatment with thalidomide
  • No history of hepatic cirrhosis
  • No history of severe hypothyroidism
  • No history of medical problem such as severe congestive heart failure or active ischemic heart disease
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No known history of deep vein thrombosis or pulmonary embolus

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior chemotherapy, biologic therapy, or radiotherapy (except for IPHC)
  • No other concurrent systemic therapy
  • No concurrent high level sedatives
  • No concurrent sedating "recreational" drugs or alcohol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310076

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University
Investigators
Study Chair: Perry Shen, MD Wake Forest University
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009