Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to several degrees above normal body temperature and infusing it into the area around the tumor may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor cells. It is not yet known whether standard therapy is more effective with or without surgery followed by mitomycin C.

PURPOSE: This randomized phase III trial is studying standard therapy with or without surgery and mitomycin C in treating patients with advanced limited peritoneal dissemination of colon cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter Reed Army Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Camptothecin; Capecitabine; Cetuximab; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Mitomycin; Mitomycins; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed colon adenocarcinoma meeting the following criteria:

• Newly diagnosed disease

• Advanced disease

• Confirmed synchronous or metachronous limited peritoneal disease dissemination

• No appendiceal or rectal cancer

• No signet ring cell type

• Disease amenable to complete cytoreduction surgery as indicated by:

• Peritoneal Cancer Index (PCI) ≤ 20 by helical CT scan and/or staging laparoscopy

• No parenchymal hepatic metastases

• No clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase), or radiological (by ultrasound, CT scan, or MRI) biliary obstruction

• No symptomatic malignant ascites requiring palliative paracentesis

• Small volume of disease in the gastro-hepatic ligament defined by a < 5 cm mass in the epigastric region on cross-sectional imaging

• No cross-sectional imaging findings indicative of multi-segmental (> 1 site) small bowel obstruction, small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening, or loss of mesenteric vascular clarity

• No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal, or peri-aortic) metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• ANC > 1,200/mm³

• WBC > 4,000/mm³

• Platelet count 150,000/mm³

• INR ≤ 1.5

• Patients on therapeutic anticoagulant for unrelated medical condition such as atrial fibrillation or anti-thrombocyte treatment allowed provided treatment can be withheld for operation

• Total serum bilirubin ≤ 1.5 mg/dL (> 1.5 mg/dL for patients with Gilbert syndrome)

• Alkaline phosphatase < 2.5 times upper limit of normal (ULN)

• AST < 1.5 times ULN

• Serum creatinine normal

• BUN normal

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No history of severe congestive heart failure or severe pulmonary disease

• Patients who are status post-revascularization procedures with satisfactory cardiac function are eligible

• No acute myocardial infarction within the past 6 months

• No significant history of a medical problem or co-morbidity (e.g., severe congestive heart failure or active ischemic heart disease) that would preclude a major abdominal operation

• No concurrent second malignancy requiring systemic therapy

• No psychiatric or addictive disorders, or other conditions that would preclude the patient from meeting the study requirements

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior second-line systemic treatment for metastatic colon adenocarcinoma

• Patients who received prior adjuvant therapy for colon adenocarcinoma and/or prior first-line systemic therapy for metastatic colon adenocarcinoma are eligible