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A Phase I/II Study of Preoperative Oxaliplatin (NSC# 266046), 5-Fluorouracil, and External Beam Radiation Therapy in Locally Advanced Rectal Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Rectum, Stage II Rectal Cancer, Stage III Rectal Cancer

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Trial Information

A Phase I/II Study of Preoperative Oxaliplatin (NSC# 266046), 5-Fluorouracil, and External Beam Radiation Therapy in Locally Advanced Rectal Cancer


PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of oxaliplatin when combined with fluorouracil and
external beam radiotherapy in patients with locally advanced adenocarcinoma of the rectum.

(Phase I closed to accrual effective 03/27/2003). II. Determine the pathological response
rate in patients treated with this preoperative regimen and surgical resection.

III.Determine the late toxicity of this preoperative regimen in these patients. IV.
Determine, in a preliminary manner, the progression-free survival, local control, and
overall survival in patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study of oxaliplatin.

Patients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days
1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in
the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, additional patients
are treated at that dose level in the phase II portion of the study. (Phase I closed to
accrual effective 03/27/2003). Patients may undergo radical resection of rectal tumor within
4-6 weeks after completion of chemoradiotherapy.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for phase I of the study (phase
I closed to accrual effective 03/27/2003) and a total of 19 patients will be accrued for
phase II of the study within 12-18 months.


Inclusion Criteria:



- Histologically proven previously untreated adenocarcinoma of the rectum thatbegins
within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy

- Locally advanced disease defined as any of the following:

- Fixed or immovable tumor on physical exam

- T4 disease with invasion of adjacent structures (e.g., pelvic sidewall,
sacral pelvis, bladder, or prostate) by CT scan, rectal ultrasound, or MRI

- T3 disease with invasion through the wall of the muscularis propria by
transrectal ultrasound, CT scan, or MRI

- No distant metastatic disease

- Performance status - ECOG 0-2

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin no greater than upper limit of normal (ULN)

- SGOT/SGPT no greater than 2.5 times ULN

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ
of the cervix

- Patients are not considered to have an active second malignancy if they have
completed therapy and are at less than 30% risk of relapse

- No prior or concurrent evidence of neuropathy

- No history of allergy to platinum compounds or antiemetics

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No prior fluorouracil or platinum-based therapy for any malignancy

- No other concurrent chemotherapy

- Hormonal therapy allowed only for non-disease related conditions (e.g., insulin for
diabetes) OR intermittently as an antiemetic (e.g., dexamethasone)

- No prior pelvic irradiation

- No concurrent antiretroviral therapy (HAART) for HIV positive patients

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The maximum tolerated dose of oxaliplatin when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinomas

Outcome Time Frame:

7 days

Safety Issue:

Yes

Principal Investigator

David Ryan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02357

NCT ID:

NCT00006094

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Rectum
  • Stage II Rectal Cancer
  • Stage III Rectal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606