A Phase II Open- Labeled, Prospective Study to Determine the Efficacy of Pre- Operative Chemotherapy With Six Cycles of Modified FOLFOX 6 Followed by Total Mesorectal Excision (TME) Followed by an Additional Six Cycles of FOLFOX 6
18 Years
N/A
Both
Colorectal Cancer
Trial Information
A Phase II Open- Labeled, Prospective Study to Determine the Efficacy of Pre- Operative Chemotherapy With Six Cycles of Modified FOLFOX 6 Followed by Total Mesorectal Excision (TME) Followed by an Additional Six Cycles of FOLFOX 6
OBJECTIVES:
Primary
- To assess the complete pathologic response rate in patients with rectal cancer treated
with modified neoadjuvant FOLFOX 6 chemotherapy followed by total mesorectal excision
and adjuvant modified FOLFOX 6 chemotherapy.
Secondary
- To observe the overall pathologic response rate in these patients.
- To correlate pathologic staging with preoperative ultrasound and pelvic MRI staging.
- To assess toxic side effects of these regimens in these patients.
- To assess patterns of disease relapse, disease-free survival outcomes, and overall
survival outcomes of these patients.
OUTLINE:
- Neoadjuvant therapy: Patients receive modified FOLFOX 6 chemotherapy comprising
oxaliplatin and leucovorin calcium IV over 2 hours on day 1 and continuous fluorouracil
IV over 46 hours on days 1-2. Treatment repeats every 14 days for 6 courses in the
absence of disease progression or unacceptable toxicity. Patients then proceed to
surgery.
- Surgery: Patients undergo total mesorectal excision by anterior resection or an
abdominal perineal resection within 4 weeks after completion of neoadjuvant therapy.
- Adjuvant therapy: Within 4 weeks after surgery, patients receive modified FOLFOX 6
chemotherapy comprising oxaliplatin and leucovorin calcium IV over 2 hours on day 1 and
continuous fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 14 days
for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life assessment questionnaires at baseline and at each
follow-up visit.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and annually thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum
- T3, N0, M0 or T1-3, N1, M0 disease as assessed by clinical exam, transrectal
ultrasound, MRI, and CT scan
- No preoperative evidence of T4, N2 or distal lesions (0-6 cm from anal
verge)
- Distal border of the tumor must be ≥ 6 cm from the anal verge on preoperative
proctoscopy with the patient in the left lateral decubitus position
- Proximal border of the tumor must be ≤ 12 cm of the anal verge by proctoscopic
examination
- No known or distant metastases
- No positive circumferential margin
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 60-100% or ECOG PS 0-1
- ANC ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN
- ALT ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- No uncontrolled intercurrent illness including, but not limited to, any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would limit compliance with study
requirements
- No serious comorbid disease, including psychiatric disorders and cardiopulmonary
disease which precludes full delivery of study treatment
- No other cancer diagnosis within the past 5 years, except nonmelanomatous skin
cancers or in situ carcinoma of the cervix
- No history of clinically significant peripheral neuropathy or current symptoms of
neuropathy, defined as ≥ grade 2 neurosensory or neuromotor toxicity
- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to fluorouracil, oxaliplatin, or leucovorin calcium
- No HIV positivity
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or pelvic irradiation
- No other concurrent investigational agents
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
- No concurrent halogenated antiviral agents (e.g., sorivudine or brivudine)
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathologic response and complete response rate
Safety Issue:
No
Principal Investigator
Peter Kozuch, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beth Israel Medical Center
Authority:
Unspecified
Study ID:
CDR0000633360
NCT ID:
NCT00831181
Start Date:
January 2009
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage II rectal cancer
- stage III rectal cancer
- adenocarcinoma of the rectum
- Rectal Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| St. Luke's-Roosevelt Hospital Center - Roosevelt Division | New York, New York 10019 |
| Beth Israel Medical Center - Philipps Ambulatory Care Center | New York, New York 10003 |
