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A PHASE I TRIAL OF COMBINED MODALITY THERAPY FOR LOCALIZED ESOPHAGEAL CANCER: CISPLATIN-PACLITAXEL FOLLOWED BY RADIATION THERAPY WITH CONCURRENT CISPLATIN AND ESCALATING DOSES OF PACLITAXEL


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

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Trial Information

A PHASE I TRIAL OF COMBINED MODALITY THERAPY FOR LOCALIZED ESOPHAGEAL CANCER: CISPLATIN-PACLITAXEL FOLLOWED BY RADIATION THERAPY WITH CONCURRENT CISPLATIN AND ESCALATING DOSES OF PACLITAXEL


OBJECTIVES: I. Estimate the maximum tolerated dose and recommend a phase II dose for
paclitaxel (TAX) when administered as a 96-hour intravenous infusion with a weekly fixed
dose of intravenous cisplatin (CDDP) during concurrent radiotherapy for patients with
localized esophageal cancer. II. Estimate the response rate of patients treated with 2
courses of TAX/CDDP induction chemotherapy and the complete response rate of patients
treated with TAX/CDDP and concurrent radiotherapy. III. Describe the toxic effects of
TAX/CDDP prior to and during radiotherapy. IV. Describe the pharmacokinetics of TAX as a
continuous infusion (CI) over 96 hours. V. Evaluate, by flow cytometry, the ability of CI
TAX to block esophageal cancer cells in the G2-M phase of the cell cycle.

OUTLINE: After the MTD of TAX is reached on Part A, new patients are entered on Part B. The
following acronyms are used: CDDP Cisplatin, NSC-119875 EBRT External-beam radiotherapy TAX
Paclitaxel (Bristol-Myers), NSC-125973 PART A: Radiotherapy plus 2-Drug Combination
Chemotherapy. EBRT using megavoltage equipment (>/= 10 MV recommended; electron boost
allowed for subclavicular fossae); plus TAX/CDDP. PART B: 2-Drug Combination Induction
Chemotherapy followed by Radiotherapy plus 2-Drug Combination Chemotherapy. TAX/CDDP;
followed by EBRT as in Part A; plus TAX/CDDP.

PROJECTED ACCRUAL: At least 3 patients/dose will be entered on Part A (up to 24 patients)
and 3-6 patients on Part B.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed epidermoid carcinoma or adenocarcinoma
of the esophagus eligible for potentially curative radiotherapy Disease in one of the
following categories: Newly diagnosed Locoregional failure after prior resection with
curative intent Positive microscopic margin after palliative resection of all gross
disease Disease clinically limited to esophagus T 1-4, any N, M0 Gastroesophageal junction
tumor allowed No positive pleural, pericardial, or peritoneal cytology No tracheobronchial
invasion on bronchoscopy, including tracheoesophageal fistula

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100%
Hematopoietic: WBC more than 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic:
Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 65 mL/min per 1.73 square meters Cardiovascular: No NYHA
class 3/4 status No cerebral vascular disease No hypertension Other: No severe
uncontrolled diabetes No uncontrolled infection No other medical condition that precludes
treatment No mental status abnormality that precludes comprehension of or compliance with
treatment No active cancer arising at another primary site other than basal cell carcinoma
of the skin or in situ cervical carcinoma

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David Paul Kelsen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064528

NCT ID:

NCT00002711

Start Date:

October 1995

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021