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A Phase II Multicenter Study of the Efficacy and Safety Study of PNU-93914 (Liposome Encapsulated Paclitaxel) in Patients With Advanced Esophageal Cancer Previously Exposed to Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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Trial Information

A Phase II Multicenter Study of the Efficacy and Safety Study of PNU-93914 (Liposome Encapsulated Paclitaxel) in Patients With Advanced Esophageal Cancer Previously Exposed to Chemotherapy


OBJECTIVES: I. Determine the antitumor activity and duration of activity of PNU-93914 in
patients with locally advanced or metastatic esophageal carcinoma. II. Determine the
objective tumor response rate and tumor response duration in patients treated with this
drug. III. Determine the survival of patients treated with this drug. IV. Determine the
safety profile of this drug in these patients. V. Determine the effect of this drug on the
quality of life of these patients. VI. Determine the time to tumor response, time to tumor
progression, and time to treatment failure in patients treated with this drug. VII. Evaluate
the change in dysphagia score in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive PNU-93914 IV over 60 minutes on day
1. Treatment repeats every 21 days for at least 2 courses in the absence of disease
progression or unacceptable toxicity. Quality of life is assessed at baseline, day 1 of each
course, and then at the final study visit. Patients are followed every 3 months for up to 2
years.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma
or adenocarcinoma of the esophagus Tumors of the gastroesophageal junction allowed if at
least 50% of the tumor involved the esophagus at time of initial diagnosis Locally
advanced or metastatic disease that is not amenable to surgery or radiotherapy with
curative intent Progressive disease after 1 chemotherapy regimen for locally advanced or
metastatic disease Relapse within 6 months of completing prior neoadjuvant chemotherapy
allowed Chemotherapy administered solely as a radiosensitizer not considered a prior
chemotherapy regimen At least 1 non-irradiated measurable target lesion At least 20 mm in
at least 1 dimension by conventional techniques OR At least 10 mm in at least 1 dimension
by spiral CT scan No known brain metastases, spinal cord compression, or carcinomatous
meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no
greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN (5
times ULN if hepatic metastases present) Renal: Creatinine no greater than 1.5 times ULN
OR Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction
within the past 6 months No unstable angina No New York Heart Association class III or IV
heart disease No severe uncontrolled cardiac arrhythmia Other: HIV negative No active
infection No other malignancy within the past 5 years except curatively treated carcinoma
in situ of the cervix, ductal carcinoma in situ of the breast, basal cell skin cancer, or
squamous cell carcinoma of the head and neck within the past 3 years No concurrent
malignancies at other sites No psychiatric or other disorder that would preclude study Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent anticancer biologic response
modifiers or immunotherapy No concurrent sargramostim (GM-CSF) No concurrent prophylactic
filgrastim (G-CSF) during first course of study Chemotherapy: See Disease Characteristics
Recovered from prior chemotherapy No prior taxane therapy No other concurrent anticancer
chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy:
See Disease Characteristics Recovered from prior radiotherapy Surgery: See Disease
Characteristics Recovered from prior surgery Other: At least 4 weeks since prior
investigational agent No other concurrent investigational therapy No concurrent
participation in other clinical study No other concurrent antitumor therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David H. Ilson, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-124

NCT ID:

NCT00016900

Start Date:

December 2000

Completion Date:

June 2001

Related Keywords:

  • Esophageal Cancer
  • stage III esophageal cancer
  • stage IV 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