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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma of the Appendix, Colorectal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

60 months after treatment

Safety Issue:

No

Principal Investigator

Perry Shen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000466311

NCT ID:

NCT00310076

Start Date:

October 2002

Completion Date:

September 2012

Related Keywords:

  • Carcinoma of the Appendix
  • Colorectal Cancer
  • 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
  • Carcinoma
  • Colorectal Neoplasms
  • Appendiceal Neoplasms
  • Colonic Neoplasms

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096