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Home > "P" Clinical Trials Conditions > Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer  Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
For Condition: recurrent pancreatic cancer,stage 4B pancreatic cancer,adenocarcinoma of the pancreas,stage 2 pancreatic cancer,stage 4A pancreatic cancer,stage 3 pancreatic cancer
Status: Suspended
Sponsor(s): Albert Einstein Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer.
Details: OBJECTIVES: - Determine the complete and partial response rates in patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas treated with sequential paclitaxel and bryostatin 1. - Determine the survival of patients treated with this regimen. - Determine the toxicity and pharmacokinetics of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the pancreas - Locally advanced and unresectable disease OR - Metastatic disease - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Indicator lesion within field of prior irradiation must have evidence of disease progression - No brain metastases PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-1 OR - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count greater than 1,500/mm^3 - Platelet count greater than 150,000/mm^3 Hepatic: - Bilirubin less than 1.5 mg/dL Renal: - Creatinine less than 1.5 mg/dL Cardiovascular: - No history of active angina - No myocardial infarction within the past 6 months - No history of significant ventricular arrhythmia requiring antiarrhythmics - Well-controlled atrial fibrillation on standard management allowed Other: - No history of HIV disease - No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - Prior T1a or b prostate cancer (detected incidentally during transurethral resection of prostate [TURP] and comprising less than 5% of resected tissue) is allowed provided PSA normal since TURP - No serious concurrent infection - No concurrent uncontrolled nonmalignant medical illness (control must not preclude study participation) - No psychiatric disorder that would preclude study participation - No other medical condition that would preclude study participation - No pre-existing neurotoxicity grade 3 or greater - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior biologic therapy (e.g., trastuzumab [Herceptin], epidermal growth factor receptor antagonists, or ras inhibitors) allowed - Prior adjuvant vaccine therapy allowed - No prior biological response modifiers - No concurrent immunotherapy Chemotherapy: - No more than 2 courses of prior standard cytotoxic chemotherapy for pancreatic cancer, including any of the following: - One course of neoadjuvant, adjuvant, or definitive chemoradiotherapy - One course of chemotherapy alone (e.g., gemcitabine or combination chemotherapy) - One course of chemoradiotherapy followed by chemotherapy alone (e.g., gemcitabine) - No prior taxanes (e.g., paclitaxel) for pancreatic cancer - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - See Chemotherapy - Prior radiotherapy allowed - No concurrent radiotherapy Surgery: - Not specified Other: - Recovered from prior therapy - At least 4 weeks since other prior therapy for this disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndreasKaubisch, Study Chair, Albert Einstein Cancer Research Center
Albert Einstein Clinical Cancer Center
Bronx, New York, 10467
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Additional Information:
Study ID Numbers: CDR0000069216; AECM-019224,NCI-5624
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031694
Other Stage 4b Pancreatic Cancer Studies:
1. Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
2. Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer
3. Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer
5. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Related Studies:
Other stage 4B pancreatic cancer Clinical Trials
Other New York Clinical Trials
Other Manhasset Clinical Trials
Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
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