DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
This trial is active, not recruiting.
|Start date||June 2001|
|Trial identifier||NCT00024375, CDR0000068926, PROTARGA-P01-00-03, THERADEX-P01-00-03, VMRC-8770|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Baltimore, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||no longer recruiting|
|New York, NY||NYU School of Medicine's Kaplan Comprehensive Cancer Center||no longer recruiting|
|Philadelphia, PA||Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||no longer recruiting|
|Seattle, WA||Virginia Mason Medical Center||no longer recruiting|
|Essen, Germany||Kliniken Essen - Mitte||no longer recruiting|
|Frankfurt, Germany||Krankenhaus Nordwest||no longer recruiting|
|Rotterdam, Netherlands||Erasmus Medical Center||no longer recruiting|
|Wolverhampton, United Kingdom||New Cross Hospital||no longer recruiting|
|Glasgow, United Kingdom||Beatson Oncology Centre||no longer recruiting|
Male or female participants at least 18 years old.
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
|Official title||Phase II Open-Label Study of Taxoperxin (DHA-Paclitaxel) Injection by 2 Hour Intravenous Infusion in Patients With Metastatic Cancer of the Pancreas|
|Description||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.|
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