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A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage III Gastric Cancer, Stage IV Gastric Cancer

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Trial Information

A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer


OBJECTIVES:

I. Determine the response rate and survival in patients with metastatic or unresectable
carcinoma of the stomach treated with bryostatin 1 and cisplatin.

II. Determine the toxic effects of this regimen in these patients. III. Determine the
molecular determinants of response to this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1
hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of
disease progression or unacceptable toxicity.


Inclusion Criteria:



- Diagnosis of metastatic or unresectable carcinoma of the stomach

- Measurable disease

- No brain metastasis

- Performance status - Karnofsky 70-100%

- More than 3 months

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL

- No history of any bleeding disorders

- Bilirubin no greater than 1.5 mg/dL

- Transaminases no greater than 2 times normal

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- No history of peptic ulceration or gastrointestinal bleeding

- No active infection

- No seizure disorder

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No other serious concurrent illness that would preclude study entry

- No medical, social, or psychological factors that would preclude study entry

- No prior chemotherapy

- No prior radiotherapy

- More than 4 weeks since prior major surgery

- Prior incomplete resection allowed

- No other prior antitumor treatment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Observed response rate, calculated as the percent of evaluable patients whose best response is a CR or PR

Outcome Description:

Associated exact 95% confidence intervals will be calculated.

Outcome Time Frame:

Up to 9 years

Safety Issue:

No

Principal Investigator

Heinz-Josef Lenz

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02361

NCT ID:

NCT00006389

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Stage III Gastric Cancer
  • Stage IV Gastric Cancer
  • Stomach Neoplasms

Name

Location

University of Southern CaliforniaLos Angeles, California  90033