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

NCT ID: NCT00310076

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2012-09-30

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 .

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.

Conditions

Carcinoma of the Appendix; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

thalidomide

Intervention Type: DRUG

Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.

surgery

Intervention Type: PROCEDURE

Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy

Interventions

thalidomide

Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.

Intervention Type: DRUG

surgery

Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Perry Shen, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

CCCWFU-59202

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-BG02-406

Identifier Type: -

Identifier Source: secondary_id

CELGENE-CCCWFU-59202

Identifier Type: -

Identifier Source: secondary_id

CDR0000466311

Identifier Type: -

Identifier Source: org_study_id