Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bronx, New York 10467


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. 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.


Study summary:

PRIMARY OBJECTIVES: I. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer. II. To determine the toxicity of therapy. III. To determine patient survival after therapy. IV. To determine Bryoststin-1 pharmacokinetics. 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.


Criteria:

Inclusion Criteria: - Histologic proof of adenocarcinoma of the pancreas confirmed at the pathology department of the enrolling institution; pathologic evidence may include fine needle aspirate material from sites of distant spread (e.g. liver, lymph- nodes, peritoneum) in patients with an unambiguous pancreatic tumor (i.e. a likely pancreatic primary) - Pancreatic cancer, which is locally advanced and considered surgically not resectable or metastatic pancreatic cancer - Patients with or without prior treatment are eligible for treatment on protocol; prior treatment may have included one treatment course of chemo/RT and/ or one course of chemotherapy, but not two prior courses of chemotherapy; chemotherapy will be defined to include standard cytotoxic treatments, as well as newer biologic agents (eg Herceptin, EGFR antagonist, Ras inhibitors) - Chemo/RT: one prior neo-adjuvant, adjuvant or definitive course of chemo/ RT (which did not include a taxane), or RT alone will be allowed - one prior course of chemotherapy alone which did not include a taxane - Radiotherapy alone - Specific sequences of prior treatment permissible for study entry: - Chemo/RT - RT alone - Chemo/RT -> progression -> chemotherapy alone (eg gemcitabine) - One course of chemotherapy alone (eg gemcitabine, or chemo combinations) - Adjuvant Vaccine -> progression -> chemotherapy alone or chemo/RT - Patients must have at least one-dimensionally measurable disease; a lesion is considered measurable if one diameter is >= 20 mm in one dimension by conventional techniques, or >= 10 mm in one dimension by spiral CT; prior radiotherapy is allowable; lesions within the prior field of radiation may only be used as indicator lesions if there has been recent evidence of disease progression at that site, defined as a 50% increase in longest diameter, or 100% increase in the product of two-dimensional radiographic evaluation (eg width x depth) since the completion of radiation therapy - ECOG performance status of 0-1 - Ability to sign an informed consent form indicating awareness of the investigational nature of this study, in keeping with the policies of the hospital - Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy; the most recent treatment for pancreatic cancer, within the limitations of allowed prior therapy must be 28 days or longer prior to enrollment on study - Absolute granulocytes > 1,500/mm^3 - Platelets > 150,000/mm^3 - Serum bilirubin < 1.5 mg/dl - Serum creatinine < 1.5 mg/dl Exclusion Criteria: - Presence of any ongoing toxic effect from prior treatment - Brain metastases - History of active angina or myocardial infarction within 6 months; history of significant ventricular arrhythmia requiring medication with antiarrhythmics; well controlled atrial fibrillation on standard management will be permitted - Pregnant or lactating women are ineligible as the effect of the drugs used in this study on a fetus or newborn child is unknown; a pregnancy test will be performed on each fertile premenopausal female prior to entry into the study; treatment may not begin until the results of the pregnancy test are ascertained - Pre-existing neurotoxicity that is graded 3+ or greater - Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy - Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol - Any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix; patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial; patients with a history of a T1a or b prostate cancer (detected incidentally at TURP and comprising less than 5% of resected tissue) may participate if the PSA remained within normal limits since TURP removal - Patients with a history of HIV disease; this is based upon the possible interactions of the bryostatin-1 or paclitaxel with anti-retroviral medications or possible immunosuppressive activity of the experimental agents - Any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in a clinical trial (for example a history of prior poor compliance with treatment) - Patients with more than the permitted number of treatments for their pancreas cancer will not be allowed to participate; specific treatment sequences that will exclude patients from study entry are: - More than one chemotherapy alone regimen (ie gemcitabine -> progression -> fluorouracil) - Any prior treatment with paclitaxel for pancreas cancer


Study is Available At:


Original ID:

NCI-2012-03003


NCT ID:

NCT00031694


Secondary ID:

01-09-224


Study Acronym:


Brief Title:

Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer


Official Title:

A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andreas Kaubisch
Principal Investigator
Montefiore Medical Center

Study Dates

Start Date:January 2002
Primary Completion Date:March 2010
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 15, 2013
First Received Date:March 8, 2002

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Bryostatin 1 pharmacokinetics
Time Frame:Week 1
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Overall survival
Time Frame:Up to 8 years
Safety Issues:False
Description:Computed using the Kaplan-Meier estimator.
Outcome Type:Secondary Outcome
Measure:Toxicity of therapy defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic functions, as indicated by physical signs, symptoms, and/or laboratory changes
Time Frame:Up to 8 years
Safety Issues:True
Description:95% confidence intervals will be computed and presented.
Outcome Type:Primary Outcome
Measure:Response rate
Time Frame:Up to 8 years
Safety Issues:False
Description:Associated 95% confidence intervals will be computed and presented.

Study Interventions

Intervention Type:Drug
Name:paclitaxel
Description:Given IV
Arm Name:Treatment (paclitaxel, bryostatin 1)
Other Name:Anzatax
Intervention Type:Drug
Name:bryostatin 1
Description:Given IV
Arm Name:Treatment (paclitaxel, bryostatin 1)
Other Name:B705008K112
Intervention Type:Other
Name:pharmacological study
Description:Correlative studies
Arm Name:Treatment (paclitaxel, bryostatin 1)
Other Name:pharmacological studies

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (paclitaxel, bryostatin 1)
Description: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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.