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A Pilot Study of Neoadjuvant FOLFOX Plus Bevacizumab Chemotherapy in Patients With Locally Advanced Colon Cancer


N/A
18 Years
90 Years
Not Enrolling
Both
Colon Cancer

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Trial Information

A Pilot Study of Neoadjuvant FOLFOX Plus Bevacizumab Chemotherapy in Patients With Locally Advanced Colon Cancer


Inclusion Criteria:



- NOTE: Patients may sign consent and be registered for this protocol prior to
completion of assessment of criteria 6.1.1 and 6.1.2, (assuming all other eligibility
criteria are met) so that endocolonic ultrasound and biopsy may be performed on
study; as these procedures may be necessary to determine TNM staging and/or
histopathology; however criteria 6.1.1 and 6.1.2 must be successfully met prior to
patient receiving chemotherapy on this trial.

- 6.1.1 Clinical T1N1-2/T2N1-2/T3N0/T3N1-2/T4Ni-N2 adenocarcinomas of the colon
determined by endocolonic ultrasound (ECUS) performed at MSKCC.

- 6.1.2 Colonoscopy with endoscopic biopsy of tumor at MSKCC for disease confirmation
and correlative studies. Pathological confirmation of adenocarcinoma or poorly
differentiated carcinoma as the primary histology.

- CT or MRI scans (done within 30 days of registration) of the Chest, Abdomen and
Pelvis all without clear evidence of distant metastatic (M1) disease.

- Candidates for systemic therapy with FOLFOX and bevacizumab based on the opinion of
the primary treating medical oncologist.

- Candidates for complete surgical resection prior to administration of any therapy.

- Performance status of ECOG 0 or 1.

- Patients must be of age ≥18 years.

- ANC ≥ 1.5 cells/mm3, PLT >150,000/mm3.

- Serum creatinine < or = to 1.5 OR creatinine clearance (measured or calculated)
greater than 60 ml/min.

Exclusion Criteria:

- Primary tumor clearly unresectable.

- Tumors with neuroendocrine histology.

- Patients with tumors that require placement of an endocolonic stent prior to
treatment initiation.

- Patients with a history of stroke or TIA.

- Patients with history of thrombotic episodes such as deep venous thrombosis,
pulmonary embolus, MI, or CVA occurring more than 12 months prior to enrollment may
be considered for protocol participation provided that they are on stable doses of
anticoagulant therapy. Similarly, patients anticoagulated for atrial fibrillation or
other conditions may participate provided that they are on stable dose of
anticoagulant therapy. Clinicians must note the higher risk of bevacizumab therapy
amongst patients with history of thromboembolic disorders and consideration for
participation is at the discretion of the treating physician.

- No other experimental therapies (including chemotherapy, radiation, hormonal
treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy,
angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide,
anti-VEGF/Flk-1 monoclonal antibody or other experimental drugs) of any kind are
permitted while the patient is receiving study treatment.

- Women of childbearing potential (WOCBP) who are unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period and for up to 6
months after the study. Subjects who are men must also agree to use effective
contraception.

- Note: Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 6 months after
the study in such a manner that the risk of pregnancy is minimized.

- WOCBP include any female who has experienced menarche and who has not undergone
successful surgical sterilization (hysterectomy, bilateral tubal ligation or
bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea ≥ 12
consecutive months; or women on hormone replacement therapy (HRT) with documented
serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using
oral, implanted or injectable contraceptive hormones or mechanical products such as
an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to
prevent pregnancy or practicing abstinence or where partner is sterile (e.g.,
vasectomy), should be considered to be of child bearing potential.

- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L
or equivalent units of HCG) within 72 hours prior to the start of study medication.

- Women who are pregnant or breast feeding. Note: women with a positive pregnancy test
on enrollment or prior to study drug administration will be removed from study.

- Patients with any other concurrent medical or psychiatric condition or disease which,
in the investigator's judgment, would make the patient inappropriate for entry into
this study.

- Patients with a history in the past five years of a prior malignancy, except for
adequately treated basal cell or squamous cell skin cancer or in situ cervical
cancer. Inadequately controlled, persistent (on more than one occasion) hypertension
(defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100
mmHg).

- Prior history of hypertensive crisis or hypertensive encephalopathy.

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months prior to Day 1

- Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation)

- History of abdominal fistula or gastrointestinal perforation within 6 months prior to
Day 1

- Serious, non-healing wound, active ulcer, or untreated bone fracture (adjuvant
trials: bone fractures must be healed

- Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening

- Known hypersensitivity to any component of bevacizumab

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the pathologic complete response (path CR) rate in patients with locally advanced (stage II or III) colon cancer to FOLFOX-bevacizumab administered as neoadjuvant.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Leonard Saltz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-162

NCT ID:

NCT00826800

Start Date:

February 2009

Completion Date:

January 2011

Related Keywords:

  • Colon Cancer
  • BEVACIZUMAB (AVASTIN)
  • FLUOROURACIL
  • LEUCOVORIN
  • OXALIPLATIN
  • Chemotherapy
  • Colonic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Mercy Medical CenterRockville Centre, New York  11570
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memoral Sloan Kettering Cancer Center@PhelpsSleepy Hollow, New York