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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 - Philadelphia Philadelphia, Pennsylvania  19107
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Virginia Mason Medical Center Seattle, Washington  98111
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410