Clinical trial NCT00006389: Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer
Official title: A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage III Gastric Cancer
Stage IV Gastric Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining cisplatin with bryostatin 1 may kill more tumor cells.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Observed Response Rate.
timeFrame: Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.
Secondary outcomes:
measure: Overall Survival
timeFrame: 18 months
measure: Progression-free Survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Heinz-Josef Lenz
role: PRINCIPAL_INVESTIGATOR
References: