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

NCT00310076 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: CDR0000466311CCCWFU-59202CCCWFU-BG02-406CELGENE-CCCWFU-59202
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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 .

Conditions

Carcinoma of the Appendix; Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to Progression

  Time to progression after surgery was recorded.

  9 hours

Secondary Outcomes (2)

• Progression Free Survival

  60 months after treatment

• Number of Events of Toxicity Graded 3 and 4

  up to 60 months

Study Arms (1)

Chemo therapy followed by thalidomide

EXPERIMENTAL

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; Procedure: surgery

Interventions

thalidomide DRUG

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

Chemo therapy followed by thalidomide

surgery PROCEDURE

Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy

Chemo therapy followed by thalidomide

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Appendiceal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Thalidomide; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases; Colonic Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Greg Russell, MS
• Organization: Comprehensive Cancer Center of Wake Forest University

grussell@wakehealth.edu

336-716-5449

Study Officials

• Perry Shen, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: April 3, 2006
• Study Start: October 1, 2002
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2012
• Last Updated: August 23, 2018
• Results First Posted: August 28, 2012

Record last verified: 2018-07

Locations

US (1)