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

NCT01167725 | Terminated Phase 3

• 3 other identifiers: CDR0000681540WRAMC-8214, Z6091NCI-2011-01572
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 2

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 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

Conditions

Colorectal Cancer

Keywords

mucinous adenocarcinoma of the colon; stage III colon cancer; stage IV colon cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

Secondary Outcomes (5)

• Progression-free survival (PFS)

• Quality of life

• Toxicity burden

• Circulating tumor cells

• Comparison of OS and PFS according to patients' peritoneal surface tumor genotype for the NAD(P)H

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients receive standard systemic therapy, at the discretion of patients' oncologist, comprising combinations of fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and/or capecitabine (including FOLFOX4, mFOLFOX6, CapeOx, or FOLFIRI), bevacizumab, or cetuximab. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may crossover to arm II.

Biological: bevacizumab; Biological: cetuximab; Drug: FOLFIRI regimen; Drug: FOLFOX regimen; Drug: capecitabine; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: oxaliplatin

Arm II

EXPERIMENTAL

Patients undergo cytoreduction surgery and hyperthermic intraperitoneal mitomycin C over 45-90 minutes. Beginning 8 weeks after surgery, patients receive standard systemic therapy as in arm I. Treatment with systemic therapy repeats for 6 courses in the absence of disease progression or unacceptable toxicity.

Biological: bevacizumab; Biological: cetuximab; Drug: FOLFIRI regimen; Drug: FOLFOX regimen; Drug: capecitabine; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: mitomycin C; Drug: oxaliplatin; Procedure: therapeutic conventional surgery

Interventions

bevacizumab BIOLOGICAL

Given IV

Arm I; Arm II

cetuximab BIOLOGICAL

Given IV

Arm I; Arm II

FOLFIRI regimen DRUG

Given IV

Arm I; Arm II

FOLFOX regimen DRUG

Given IV

Arm I; Arm II

capecitabine DRUG

Given IV

Arm I; Arm II

fluorouracil DRUG

Given IV

Arm I; Arm II

irinotecan hydrochloride DRUG

Given IV

Arm I; Arm II

leucovorin calcium DRUG

Given IV

Arm I; Arm II

mitomycin C DRUG

Given intraperitoneally

Arm II

oxaliplatin DRUG

Given IV

Arm I; Arm II

therapeutic conventional surgery PROCEDURE

Patients undergo cytoreductive surgery

Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

St. Agnes Hospital Cancer Center

Baltimore, Maryland, 21229, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Bevacizumab; Cetuximab; Folfox protocol; Capecitabine; Fluorouracil; Irinotecan; Leucovorin; Mitomycin; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Coordination Complexes

Study Officials

• Alexander Stojadinovic, MD

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (2)