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

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

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 .

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Carcinoma of the Appendix
• Intervention / Treatment: Drug: thalidomide; Procedure: surgery

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157-1096
      • Wake Forest University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Progression	Time to progression after surgery was recorded.	9 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival		60 months after treatment
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: March 29, 2006
• First Submitted That Met QC Criteria: March 29, 2006
• First Posted (ESTIMATE): April 3, 2006

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: stage IV rectal cancer; stage IV colon cancer; recurrent colon cancer; recurrent rectal cancer; stage III colon cancer; stage II rectal cancer; stage III rectal cancer; stage II colon cancer; carcinoma of the appendix
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Thalidomide
• Other Study ID Numbers: CDR0000466311; CCCWFU-59202; CCCWFU-BG02-406; CELGENE-CCCWFU-59202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No