DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic pancreatic cancer.

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Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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DHA-paclitaxel

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No