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DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer Clinical research trials and DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer clinical trial. Subjects often receive the most expert healthcare possible for their DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer  DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
For Condition: stage 3 pancreatic cancer,unspecified adult solid tumor, protocol specific,stage 4B pancreatic cancer,recurrent pancreatic cancer,stage 4A pancreatic cancer,stage 2 pancreatic cancer
Status: Recruiting
Sponsor(s): Theradex ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of DHA-paclitaxel with or without gemcitabine in treating patients who have advanced solid tumors or unresectablepancreatic cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of DHA-paclitaxel with and without gemcitabine in patients with advanced solid tumors. - Determine the qualitative and quantitative toxicity and reversibility of toxicity of these regimens in these patients. - Determine the pharmacokinetics of these regimens in these patients. - Determine the antitumor activity of these regimens in these patients. OUTLINE: This is a two-part, open-label, dose-escalation study. - Patients are assigned to 1 of 2 treatment groups. - Group I: Patients receive DHA-paclitaxel IV over 2 hours on days 1, 8, and 15. - Group II: Patients receive DHA-paclitaxel as in group I and gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses in both groups repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with at least stable disease receive up to 6 courses. Cohorts of 3-6 patients in each group receive escalating doses of DHA-paclitaxel with and without gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Part II: Patients receive DHA-paclitaxel and gemcitabine as in part I, group II, at the recommended phase II dose. Patients are followed for up to 30 days. PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for part I of this study. A maximum of 20 patients will be accrued for part II of this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Part I: Histologically or cytologically confirmed malignant solid tumor that is refractory to conventional therapy or for which no conventional therapy exists - Part II: Diagnosis of unresectable pancreatic cancer - Not suitable for local radiotherapy - Measurable disease - No known or clinical evidence of active CNS metastasis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 (part I) - ECOG 0-1 (part II) 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) - Transaminases 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 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known hypersensitivity to Cremophor - No other serious or unstable medical condition - No psychiatric disorder that would preclude study entry - No concurrent active infection requiring anti-infectants (e.g., antibiotics, antivirals, or antifungals) - No other malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix or other cancer curatively treated by surgery alone with a disease-free survival of more than 5 years (part II) PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy - No concurrent prophylactic filgrastim (G-CSF) during the first 2 courses of study therapy Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No more than 6 prior courses of an alkylating agent* - No more than 6 prior courses of carboplatin* - No more than 2 prior courses of mitomycin or nitrosoureas* - No more than 2 prior chemotherapy regimens for advanced disease** - No prior taxane therapy** - No other concurrent chemotherapy NOTE: *Part I NOTE: **Part II Endocrine therapy - Concurrent hormonal therapy is allowed if initiated prior to study Radiotherapy - See Disease Characteristics - More than 4 weeks since prior large-field radiotherapy - No prior radiotherapy to 25% or more of the bone marrow - Prior palliative radiotherapy for metastatic disease in a nonmeasurable region is allowed - No concurrent radiotherapy, including whole-brain radiotherapy for CNS metastasis - Concurrent local radiotherapy for painful bone lesions or those threatening bone integrity is allowed Surgery - More than 14 days since prior major surgery Other - Recovered from prior therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VincentPicozzi, Study Chair, Cancer Institute at Virginia Mason Medical Center
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Paula Fracasso 314-454-8817
Cancer Institute at Virginia Mason Medical Center *Recruiting*
Seattle, Washington, 98101-2795
United States
Recruiting Vincent Picozzi 206-223-6193
Additional Information:
Study ID Numbers: CDR0000269916; VMRC-8846,THERADEX-P01-02-12,PROTARGA-P01-02-12
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059774
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
2. BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery
3. CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
4. Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
5. Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
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