Status:
TERMINATED
Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief 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 ab...
Detailed Description
OBJECTIVES: Primary * To compare the overall survival (OS) of patients with advanced limited peritoneal dissemination of colon adenocarcinoma treated with systemic therapy with vs without cytoreduct...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT01167725
Start Date
August 1 2010
End Date
January 1 2012
Last Update
December 27 2024
Active Locations (2)
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1
St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States, 21229
2
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096