Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00004144
First received: December 10, 1999
Last updated: April 22, 2014
Last verified: April 2014

December 10, 1999
April 22, 2014
May 2000
December 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00004144 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not responded to previous treatment.

OBJECTIVES:

  • Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer.
  • Access the pattern of toxicity of this drug regimen in this patient population.
  • Determine the objective response rate, duration of response, and overall survival in patients treated with this drug regimen.
  • Determine the influence of bryostatin 1 on the pharmacokinetics of gemcitabine.

OUTLINE: This is a dose escalation study.

Patients receive gemcitabine IV over 30 minutes, immediately followed by bryostatin 1 IV over 24 hours, weekly for 3 weeks (days 1, 8, and 15). Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of gemcitabine and bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxic effects.

PROJECTED ACCRUAL: Approximately 2-3 patients per month will be accrued for this study.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: bryostatin 1
  • Drug: gemcitabine hydrochloride
Experimental: bryostatin 1 & gemcitabine hydrochloride
Interventions:
  • Drug: bryostatin 1
  • Drug: gemcitabine hydrochloride
El-Rayes BF, Gadgeel S, Shields AF, Manza S, Lorusso P, Philip PA. Phase I study of bryostatin 1 and gemcitabine. Clin Cancer Res. 2006 Dec 1;12(23):7059-62.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2006
December 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven advanced cancer (except hematological cancers) for which there is no standard therapy or have failed standard therapies
  • Measurable or evaluable disease
  • Clinically controlled brain metastases allowed

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Hemoglobin at least 8.0 g/dL
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN) (elevated bilirubin due to Gilbert's syndrome allowed if direct bilirubin normal)
  • AST less than 2.5 times ULN

Renal:

  • Creatinine normal

Cardiovascular:

  • No active cardiac disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No concurrent bacterial infection requiring antibiotics
  • No serious concurrent medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • At least 3 weeks since systemic cytotoxic chemotherapy (including gemcitabine) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • Prior hormonal therapy allowed
  • No concurrent hormonal therapy (excluding contraceptives, appetite stimulants, or replacement steroids)

Radiotherapy:

  • At least 3 weeks since radiotherapy to large areas of active bone marrow and recovered
  • No concurrent radiotherapy

Surgery:

  • Recovered from prior major surgery

Other:

  • No concurrent antiviral nucleosides
  • At least 1 month since prior investigational agents
  • No other concurrent experimental medications
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004144
CDR0000067375, P30CA022453, WSU-Z-2021, NCI-T99-0014
Yes
Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
April 2014

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