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

Colorectal Cancer Clinical Trial

Official title:

Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From Colorectal/Appendiceal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310076
• Other study ID #: CDR0000466311
• Secondary ID: CCCWFU-59202CCCW
• Status: Completed
• Phase: Phase 2
• Start date: October 2002
• Est. completion date: September 2012

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendiceal Neoplasms
• Carcinoma of the Appendix
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression	Time to progression after surgery was recorded.	9 hours
Secondary	Progression Free Survival		60 months after treatment
Secondary	Number of Events of Toxicity Graded 3 and 4	Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported	up to 60 months