DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: DHA-paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
| Study Start Date: | June 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, New York | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, Pennsylvania | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| Germany | |
| Kliniken Essen - Mitte | |
| Essen, Germany, D-45136 | |
| Krankenhaus Nordwest | |
| Frankfurt, Germany, D-60488 | |
| Netherlands | |
| Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 EA | |
| United Kingdom | |
| New Cross Hospital | |
| Wolverhampton, England, United Kingdom, WV10 0QP | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Study Chair: | Ross C. Donehower, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00024375 History of Changes |
| Other Study ID Numbers: | CDR0000068926, THERADEX-P01-00-03, PROTARGA-P01-00-03, VMRC-8770 |
| Study First Received: | September 13, 2001 |
| Last Updated: | February 17, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent pancreatic cancer stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Paclitaxel |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013