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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

Primary Purpose

Carcinoma of the Appendix, Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
thalidomide
surgery
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of the Appendix focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemo therapy followed by thalidomide

Arm Description

After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.

Outcomes

Primary Outcome Measures

Time to Progression
Time to progression after surgery was recorded.

Secondary Outcome Measures

Progression Free Survival
Number of Events of Toxicity Graded 3 and 4
Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported

Full Information

First Posted
March 29, 2006
Last Updated
July 24, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00310076
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemo therapy followed by thalidomide
Arm Type
Experimental
Arm Description
After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Intervention Type
Drug
Intervention Name(s)
thalidomide
Intervention Description
Patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy
Primary Outcome Measure Information:
Title
Time to Progression
Description
Time to progression after surgery was recorded.
Time Frame
9 hours
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
60 months after treatment
Title
Number of Events of Toxicity Graded 3 and 4
Description
Adverse events with Common Toxicity Criteria grades of 3 and 4 are reported
Time Frame
up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry Shen, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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