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 has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00310076
First received: March 29, 2006
Last updated: October 16, 2012
Last verified: October 2012
  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: surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 60 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: October 2002
Study Completion Date: September 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemo therapy followed by thalidomide
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Drug: thalidomide
Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Procedure: surgery
Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy

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.

  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
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Perry Shen, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00310076     History of Changes
Other Study ID Numbers: CDR0000466311, CCCWFU-59202, CCCWFU-BG02-406, CELGENE-CCCWFU-59202
Study First Received: March 29, 2006
Results First Received: July 24, 2012
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
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

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Appendiceal Neoplasms
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cecal Neoplasms
Cecal Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014