Combination Chemotherapy in Treating Patients Undergoing Surgery for Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00831181
First received: January 27, 2009
Last updated: June 16, 2009
Last verified: June 2009
  Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may kill more tumor cells and may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving oxaliplatin, leucovorin, and fluorouracil after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy works in treating patients undergoing surgery for rectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: FOLFOX regimen
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Procedure: therapeutic surgical procedure
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pathologic response and complete response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Locoregional control [ Designated as safety issue: No ]
  • Complete resectability rates [ Designated as safety issue: No ]
  • Ability of high resolution pelvic MRI to assess locoregional response and predict adequacy of the circumferential margin after total mesorectal excision (TME) [ Designated as safety issue: No ]
  • Sphincter preservation [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Preservation of sexual, urinary, and bowel function [ Designated as safety issue: No ]
  • Patterns of disease failure, including local recurrence and distant metastasis assessed by CT scan [ Designated as safety issue: No ]
  • Quality of life at baseline and annually following TME [ Designated as safety issue: No ]
  • Comparison of preoperative stage with post-treatment pathologic stage [ Designated as safety issue: No ]
  • Comparison of preoperative staging with pelvic MRI vs endorectal ultrasound [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: January 2009
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831181

Locations
United States, New York
Beth Israel Medical Center - Philipps Ambulatory Care Center Recruiting
New York, New York, United States, 10003
Contact: Clinical Trials Office - Beth Israel Medical Center - Philipps    212-844-8060      
St. Luke's-Roosevelt Hospital Center - Roosevelt Division Recruiting
New York, New York, United States, 10019
Contact: Tahir Mirzoyev    212-523-7289      
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Peter Kozuch, MD Beth Israel Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Peter Kozuch, Beth Israel Medical Center - Philipps Ambulatory Care Center
ClinicalTrials.gov Identifier: NCT00831181     History of Changes
Other Study ID Numbers: CDR0000633360, BIMCP-OX-08-006, AVENTIS-BIMCP-OX-08-006
Study First Received: January 27, 2009
Last Updated: June 16, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II rectal cancer
stage III rectal cancer
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on July 29, 2014