Clinical trial NCT00310076: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-04-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to Progression
timeFrame: 9 hours
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 60 months after treatment
measure: Number of Events of Toxicity Graded 3 and 4
timeFrame: up to 60 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Perry Shen, MD
role: STUDY_CHAIR
References: