Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer
NCT ID: NCT01167725
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
340 participants
INTERVENTIONAL
2010-08-31
2012-01-31
Brief Summary
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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
Detailed Description
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Primary
* To compare the overall survival (OS) of patients with advanced limited peritoneal dissemination of colon adenocarcinoma treated with systemic therapy with vs without cytoreduction surgery and hyperthermic intraperitoneal mitomycin C.
* To compare the relative OS at 1 year of patients treated with these regimens.
Secondary
* To compare the progression-free survival (PFS) of patients treated with these regimens.
* To compare the relative PFS at 1 year of patients treated with these regimens.
* To compare the quality of life of patients treated with these regimens.
* To compare the toxicity burden of these regimens in these patients.
* To compare the OS and PFS according to patients' peritoneal surface tumor genotype for the NAD(P)H (quinone oxidoreductase 1 \[NQO1\] 609C \>T polymorphism \[wild type vs heterozygous/homozygous mutant\]) in patients treated with these regimens.
* To compare circulating tumor cells in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to presentation (synchronous vs metachronous carcinomatosis), ECOG performance status (0 vs 1), disease volume (measurable vs non-measurable), prior first-line therapy for advanced disease (chemo-naïve vs prior first-line therapy), planned chemotherapy (oxaliplatin vs irinotecan vs fluorouracil/leucovorin calcium vs capecitabine), and planned biologic therapy (bevacizumab vs cetuximab vs none). Patients are randomized to 1 of 2 treatment arms.
* Arm I: 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) with or without bevacizumab (beginning 4-6 weeks after major surgery) or cetuximab\*. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may crossover to arm II.
NOTE: \*For patients with KRAS wild-type tumors.
* Arm II: 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.
Blood and tissue samples may be collected from patients for correlative studies.
Patients complete SF-36 Health Survey; Functional Assessment of Cancer Therapy-Colorectal (FACT-C); Feeling Sad, Down, or Depressed (CES-D); and a Brief Pain Inventory quality-of-life questionnaires at baseline and then periodically during study.
After completion of study therapy, patients are followed up periodically for 5 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Study Groups
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Arm I
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.
bevacizumab
Given IV
cetuximab
Given IV
FOLFIRI regimen
Given IV
FOLFOX regimen
Given IV
capecitabine
Given IV
fluorouracil
Given IV
irinotecan hydrochloride
Given IV
leucovorin calcium
Given IV
oxaliplatin
Given IV
Arm II
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.
bevacizumab
Given IV
cetuximab
Given IV
FOLFIRI regimen
Given IV
FOLFOX regimen
Given IV
capecitabine
Given IV
fluorouracil
Given IV
irinotecan hydrochloride
Given IV
leucovorin calcium
Given IV
mitomycin C
Given intraperitoneally
oxaliplatin
Given IV
therapeutic conventional surgery
Patients undergo cytoreductive surgery
Interventions
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bevacizumab
Given IV
cetuximab
Given IV
FOLFIRI regimen
Given IV
FOLFOX regimen
Given IV
capecitabine
Given IV
fluorouracil
Given IV
irinotecan hydrochloride
Given IV
leucovorin calcium
Given IV
mitomycin C
Given intraperitoneally
oxaliplatin
Given IV
therapeutic conventional surgery
Patients undergo cytoreductive surgery
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Alexander Stojadinovic, MD
Role: PRINCIPAL_INVESTIGATOR
Walter Reed Army Medical Center
Locations
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St. Agnes Hospital Cancer Center
Baltimore, Maryland, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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WRAMC-8214, Z6091
Identifier Type: -
Identifier Source: secondary_id
CDR0000681540
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2011-01572
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000681540
Identifier Type: -
Identifier Source: org_study_id