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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.
First Received: March 8, 2002   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031694
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: bryostatin 1
Drug: paclitaxel
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Sequential Paclitaxel And Bryostatin-1 For Patients With Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031694

Locations
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10467
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
North Shore University Hospital
Manhasset, New York, United States, 11030
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Study Chair: Andreas Kaubisch, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069216, AECM-019224, NCI-5624
Study First Received: March 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00031694     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Adjuvants, Immunologic
Endocrine System Diseases
Antimitotic Agents
Bryostatin 1
Pancrelipase
Recurrence
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Mitosis Modulators
Physiological Effects of Drugs
Adjuvants, Immunologic
Endocrine System Diseases
Antimitotic Agents
Bryostatin 1
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Pancreatic Diseases
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009