Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00031694
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Duration (Months): 97
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer	Drug: paclitaxel; Drug: bryostatin 1	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer.

2. To determine the toxicity of therapy. III. To determine patient survival after therapy.

3. To determine Bryostatin-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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer
• Study Start Date: Mar 1, 2002
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (paclitaxel, bryostatin 1) 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.	Drug: paclitaxel; Given IV; Other Names: Anzatax Asotax TAX Taxol ; Drug: bryostatin 1; Given IV; Other Names: B705008K112 BRYO Bryostatin

Outcome Measures

Primary Outcome Measures

1. Response Rate of at Least 30% [Up to 8 years]

   Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).

Secondary Outcome Measures

1. Number of Participants With Adverse Events [Up to 8 years]

2. Overall Survival [Up to 8 years]

   Computed using the Kaplan-Meier estimator.

Other Outcome Measures

1. Bryostatin 1 Pharmacokinetics [Week 1]

   Not done-study terminated early

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologic proof of adenocarcinoma of the pancreas that is locally advanced and considered surgically not resectable or metastatic

• 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;

• Measurable disease

• 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

• 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

• HIV infection

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467-2490

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Andreas Kaubisch, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00031694
• Other Study ID Numbers: NCI-2012-03003; 01-09-224; NCI-5624; N01CM17103
• First Posted: Jan 27, 2003
• Last Update Posted: Jun 11, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Adenocarcinoma; Pancreatic Neoplasms; Carcinoma, Acinar Cell; Paclitaxel; Bryostatin 1

Study Results

Participant Flow

Recruitment Details	A total of 19 patients were enrolled from 5 centers between March 2002 and October 2003.

Arm/Group Title	Treatment (Paclitaxel, Bryostatin 1)
Arm/Group 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. paclitaxel: Given IV bryostatin 1: Given IV pharmacological study: Correlative studies
Period Title: Overall Study
STARTED	19
COMPLETED	0
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Treatment (Paclitaxel, Bryostatin 1)
Arm/Group 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. paclitaxel: Given IV bryostatin 1: Given IV pharmacological study: Correlative studies
Overall Participants	19
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	56.0
Sex: Female, Male (Count of Participants)
Female	7 36.8%
Male	12 63.2%
Race/Ethnicity, Customized (participants) [Number]
Non-Hispanic whites	13 68.4%
Non-Hispanic black	3 15.8%
Hispanic	3 15.8%

Outcome Measures

1. Primary Outcome

Title	Response Rate of at Least 30%
Description	Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame	Up to 8 years

Outcome Measure Data

Analysis Population Description

data not met

Arm/Group Title	Treatment (Paclitaxel, Bryostatin 1)
Arm/Group 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. paclitaxel: Given IV bryostatin 1: Given IV pharmacological study: Correlative studies
Measure Participants	19
Number [participants]	0 0%

2. Secondary Outcome

Title	Number of Participants With Adverse Events
Time Frame	Up to 8 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Paclitaxel, Bryostatin 1)
Arm/Group 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. paclitaxel: Given IV bryostatin 1: Given IV
Measure Participants	19
Count of Participants [Participants]	10 52.6%

3. Secondary Outcome

Title	Overall Survival
Description	Computed using the Kaplan-Meier estimator.
Time Frame	Up to 8 years

Outcome Measure Data

Analysis Population Description

Patients with locally advanced or metastatic pancreatic adenocarcinoma received a total of 52 cycles of therapy.

Arm/Group Title	Treatment (Paclitaxel, Bryostatin 1)
Arm/Group 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. paclitaxel: Given IV bryostatin 1: Given IV pharmacological study: Correlative studies
Measure Participants	19
Count of Participants [Participants]	17 89.5%

4. Other Pre-specified Outcome

Title	Bryostatin 1 Pharmacokinetics
Description	Not done-study terminated early
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Treatment (Paclitaxel, Bryostatin 1)
Arm/Group 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. paclitaxel: Given IV bryostatin 1: Given IV pharmacological study: Correlative studies
All Cause Mortality
	Treatment (Paclitaxel, Bryostatin 1)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment (Paclitaxel, Bryostatin 1)
	Affected / at Risk (%)	# Events
Total	10/19 (52.6%)
Blood and lymphatic system disorders
Leukopenia	5/19 (26.3%)
Anemia	2/19 (10.5%)
General disorders
Death	2/19 (10.5%)
Abdominal pain	2/19 (10.5%)
Hepatobiliary disorders
ALT/SGPT	2/19 (10.5%)
AST/SGOT	2/19 (10.5%)
Infections and infestations
Infection	2/19 (10.5%)
Musculoskeletal and connective tissue disorders
Myalgia	2/19 (10.5%)
Vascular disorders
Thrombosis/embolism	2/19 (10.5%)
Hemorrhage	2/19 (10.5%)
Other (Not Including Serious) Adverse Events
	Treatment (Paclitaxel, Bryostatin 1)
	Affected / at Risk (%)	# Events
Total	7/19 (36.8%)
Blood and lymphatic system disorders
Leukopenia	1/19 (5.3%)
Anemia	4/19 (21.1%)
General disorders
Abdominal pain	3/19 (15.8%)
Infections and infestations
Infection	1/19 (5.3%)
Musculoskeletal and connective tissue disorders
Myalgia	7/19 (36.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.