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Phase II Open-Label Study of Taxoperxin (DHA-Paclitaxel) Injection by 2 Hour Intravenous Infusion in Patients With Metastatic Cancer of the Pancreas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Phase II Open-Label Study of Taxoperxin (DHA-Paclitaxel) Injection by 2 Hour Intravenous Infusion in Patients With Metastatic Cancer of the Pancreas


OBJECTIVES:

- Determine the tumor response rate, duration of response, and time to disease
progression in patients with metastatic carcinoma of the pancreas treated with
DHA-paclitaxel.

- Determine the overall survival of patients treated with this drug.

- Determine the toxicity profile of this drug in these patients.

- Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in
the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 2 courses, and at completion of treatment.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed carcinoma of the pancreas

- Metastatic disease

- Measurable disease

- Lesions within a previously irradiated field are not considered measurable

- No islet cell tumors, lymphoma, or sarcoma of the pancreas

- No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

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

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No uncontrolled ventricular arrhythmia

- No myocardial infarction within the past 3 months

- No superior vena cava syndrome

Neurologic:

- No peripheral neuropathy greater than grade 1

- No uncontrolled major seizure disorder

- No spinal cord compression

Other:

- No concurrent serious infection requiring parenteral therapy

- No unstable or serious concurrent medical condition

- No other prior malignancy except:

- Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR

- Other cancer curatively treated with surgery alone that has not recurred for
more than 5 years

- No psychiatric disorder that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy

Chemotherapy:

- No prior chemotherapy for metastatic disease

- Prior adjuvant chemoradiotherapy allowed

- At least 28 days since prior chemotherapy and recovered

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except megestrol

Radiotherapy:

- See Disease Characteristics

- Prior adjuvant chemoradiotherapy allowed

- At least 28 days since prior large-field radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- At least 14 days since prior major surgery and recovered

Other:

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ross C. Donehower, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068926

NCT ID:

NCT00024375

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Virginia Mason Medical CenterSeattle, Washington  98111
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410