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A Phase I Study of Oxaliplatin in Combination With Continuous Infusion 5-Fluorouracil and Radiation in Esophageal Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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Trial Information

A Phase I Study of Oxaliplatin in Combination With Continuous Infusion 5-Fluorouracil and Radiation in Esophageal Cancer


OBJECTIVES:

- Determine the maximum tolerated dose and dose-limiting toxicity of oxaliplatin when
given in combination with continuous-infusion fluorouracil and radiotherapy in patients
with primary cancer of the thoracic esophagus or gastroesophageal junction.

- Determine the pharmacokinetics of this regimen in this patient population.

- Assess somatic p53 mutations in cancer of the esophagus and determine their relation to
therapeutic response induced by this regimen.

- Assess, in a preliminary manner, the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of oxaliplatin and fluorouracil.

Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV
continuously on days 8-42. Patients also undergo radiotherapy once daily, 5 days a week, for
6 weeks beginning on day 8.

Patients without evidence of distant disease or unresectable local regional invasion undergo
esophageal resection between days 63-70 (within 3-4 weeks after completion of
chemoradiotherapy). Patients then receive oxaliplatin as above on days 105, 119, and 133 and
fluorouracil as above on days 105-147.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within
approximately 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed primary squamous cell carcinoma or
adenocarcinoma of the thoracic esophagus (below 20 cm from incisors) or
gastroesophageal (GE) junction

- Stage I-III

- Bronchoscopy with biopsy and cytology required if primary esophageal cancer is
less than 26 cm from incisors

- No disease outside esophagus and peri-esophageal soft tissue

- GE junction tumors must be confined to no greater than 2 cm into the gastric cardia

- Supraclavicular lymph nodes at station 1 must be less than 1.5 cm or nonpalpable by
physical examination

- Nodes 1.5 cm or greater or palpable by physical examination must be confirmed to
be nonmalignant by biopsy

- Subdiaphragmatic lymph nodes at stations 15-20 must be no greater than 1.5 cm

- No recurrent disease

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm3

- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- Bilirubin normal

- AST/ALT no greater than 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine normal OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No grade 2 peripheral neuropathy

- No history of allergy to platinum compounds

- No history of allergy to antiemetics appropriate for administration in conjunction
with protocol-directed chemotherapy

- No other concurrent uncontrolled illness

- No ongoing or active infection

- No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No colony-stimulating factor therapy during first study course

Chemotherapy:

- No prior chemotherapy for esophageal cancer

- At least 4 weeks since other prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy for esophageal cancer

- At least 4 weeks since other prior radiotherapy

Surgery:

- No prior resection or attempted resection of esophageal cancer

Other:

- No other concurrent investigational drugs

- No other concurrent commercial agents or therapies for esophageal cancer

- No concurrent highly active antiretroviral agents (HAART) for HIV-positive patients

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lawrence P. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albany Medical College

Authority:

United States: Federal Government

Study ID:

CDR0000067504

NCT ID:

NCT00004257

Start Date:

January 2000

Completion Date:

January 2004

Related Keywords:

  • Esophageal Cancer
  • stage I esophageal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263