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Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Philip A. Philip, MD, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067375

NCT ID:

NCT00004144

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201