This trial is active, not recruiting.

Condition pancreatic cancer
Treatment dha-paclitaxel
Phase phase 2
Sponsor Theradex
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

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).