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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00310076
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : August 28, 2012
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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 .


Condition or disease Intervention/treatment Phase
Carcinoma of the Appendix Colorectal Cancer Drug: thalidomide Procedure: surgery Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2002
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to Progression [ Time Frame: 9 hours ]
    Time to progression after surgery was recorded.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 60 months after treatment ]
  2. Number of Events of Toxicity Graded 3 and 4 [ Time Frame: up to 60 months ]
    Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310076


Locations
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United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Study Chair: Perry Shen, MD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00310076    
Other Study ID Numbers: CDR0000466311
CCCWFU-59202
CCCWFU-BG02-406
CELGENE-CCCWFU-59202
First Posted: April 3, 2006    Key Record Dates
Results First Posted: August 28, 2012
Last Update Posted: August 23, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
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:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Thalidomide
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents