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Phase 2 N=90 Treatment

Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery

Colorectal Cancer

Enrolled (actual)
90
Serious AEs
1.1%
Results posted
Jan 2013
Primary outcome: Primary: Major Morbidity Related to the Intact Primary Tumor — 16.3 probability of major morbidity (%)

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
bevacizumab (Biological); fluorouracil (Drug); leucovorin (Drug); oxaliplatin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
NSABP Foundation Inc
Primary completion
Nov 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Major Morbidity Related to the Intact Primary Tumor
16.3
SECONDARY
Local Complications as Assessed by Colonic Obstruction Requiring Hospitalization (But Not Surgery) for Medical Management, Stent Placement, Laser Treatment, or Fulguration
SECONDARY
Local Complications as Assessed by Gastrointestinal Bleeding Requiring Transfusion But Not Requiring Surgery
SECONDARY
Local Complications as Assessed by Fistula Formation (Self-draining Enterocutaneous Fistula and Intra-abdominal Abscess Requiring Percutaneous Drainage) Not Requiring Surgery
SECONDARY
Local Complications as Assessed by Other Events Related to the Intact Primary Tumor Which Require Hospitalization But Not Surgery
SECONDARY
Serious Adverse Events (Grades 3, 4, and 5) as Defined by CTCAE v3.0
SECONDARY
Overall Survival as Measured by Death From Any Cause

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colon cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed by surgery.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the colon
  • No histological findings other than adenocarcinoma of the colon
  • If the primary colon tumor and the metastatic lesions have been identified at the same time and it is not possible to biopsy the colonic lesion, the patient will be eligible without histologic confirmation of the primary cancer of the colon as long as other radiographic studies or scans document the characteristics of a colon cancer AND the biopsy of a metastatic site confirms diagnosis of adenocarcinoma suggestive of a primary tumor of the colon
  • Unresected primary tumor of the colon AND radiographically confirmed metastatic colon cancer (single or multiple sites of metastases) that are not considered surgically resectable for cure by chest imaging and CT scan or MRI of the abdomen within the past 4 weeks and by endoscopy within the past 8 weeks
  • Asymptomatic primary tumor
  • No obstruction, perforation, or active bleeding requiring transfusion
  • Distal extent of the tumor must be ≥ 12 cm from the anal verge on endoscopy
  • Not a candidate for curative surgical resection of all metastatic and colon primary tumors
  • No evidence of Central Nervous System (CNS) metastases
  • No recurrent local or metastatic disease after prior adjuvant therapy
  • No diagnosis of rectal carcinoma

PATIENT CHARACTERISTICS:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Absolute neutrophil count ≥ 1200/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 3.0 times ULN (≤ 5.0 times ULN if liver metastases are present)
  • Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if liver metastases are present)
  • Creatinine 150/100 mm Hg
  • No nonmalignant systemic disease that would preclude any of the study therapy drugs, compromise the safety of the patient, or inhibit the patient's ability to participate in the study, including any of the following:
  • New York Heart Association class III or IV cardiac disease
  • Myocardial infarction within the past 6 months
  • Unstable angina within the past 6 months
  • Symptomatic arrhythmia
  • No transient ischemic attack or cerebrovascular accident within the past 6 months
  • No symptomatic peripheral vascular ischemia within the past 6 months
  • No arterial thrombotic event within the past 6 months
  • No gastroduodenal ulcer(s) determined by endoscopy to be active
  • No gastrointestinal perforation within the past 12 months
  • No serious or nonhealing wound, skin ulcer, or bone fracture
  • No significant traumatic injury within the past 28 days
  • No significant episodes of acute bleeding requiring blood transfusion within the past 6 months
  • No clinically significant (≥ grade 2) peripheral neuropathy (neurosensory or neuromotor toxicity)
  • No pulmonary fibrosis or interstitial pneumonitis by chest x-ray
  • No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting study requirements

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy, radiation therapy, or surgery for this malignancy
  • No prior endoscopic management of this malignancy other than biopsy, including endoscopic stent placement, fulguration, or laser treatment
  • More than 30 days since prior investigational drugs
  • More than 28 days since prior major surgical procedure or open biopsy
  • More than 7 days since prior core biopsy or other minor procedure, excluding placement of a vascular access device
  • No concurrent major surgery unrelated to intact primary colon cancer
  • No concurrent radiotherapy
  • No concurrent filgrastim (G-CSF) or pegfilgrastim as primary prophylaxis for neutropenia
  • No concurrent halogenated antiviral agents
  • No other concurrent investigational drugs
  • No other concurrent antineoplastic agents
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00321828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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