Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer

Stage IV Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006389
• Other study ID #: NCI-2012-02361
• Secondary ID: NCI-2012-02361CH
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2000
• Last updated: September 26, 2014
• Start date: October 2000
• Est. completion date: March 2010

Study information

• Verified date: October 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• bryostatin 1
Given IV
• cisplatin
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed Response Rate.	All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 "target lesions" were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference; The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval.	Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.	No
Secondary	Overall Survival	Overall survival was estimated according to the Kaplan-Meier product-limit method.	18 months	No
Secondary	Progression-free Survival	Progression-free survival was estimated according to the Kaplan-Meier product-limit method	18 months	No