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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
Not Enrolling
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


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:


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:


Principal Investigator

David Ryan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




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



Cancer and Leukemia Group BChicago, Illinois  60606