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Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
This study is ongoing, but not recruiting participants.
Study NCT00031694   Information provided by National Cancer Institute (NCI)
First Received: March 8, 2002   Last Updated: July 23, 2008   History of Changes

March 8, 2002
July 23, 2008
January 2002
 
 
 
Complete list of historical versions of study NCT00031694 on ClinicalTrials.gov Archive Site
 
 
 
Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
A Phase II Study Of Sequential Paclitaxel And Bryostatin-1 For Patients With Advanced Pancreatic Cancer

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.

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.

Phase II
Interventional
Treatment, Open Label
Pancreatic Cancer
  • Drug: bryostatin 1
  • Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00031694
 
CDR0000069216, AECM-019224, NCI-5624
Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Study Chair: Andreas Kaubisch, MD Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP