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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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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 DivisionNew York, New York  10019
Beth Israel Medical Center - Philipps Ambulatory Care CenterNew York, New York  10003