Phase 2 N=12 Treatment

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

Stage III Gastric Cancer · Stage IV Gastric Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00006389 ↗

Enrolled (actual)

Serious AEs

41.7%

Results posted

Oct 2014

Primary outcome: Primary: Observed Response Rate. — 0 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bryostatin 1 (Drug); cisplatin (Drug); laboratory biomarker analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Observed Response Rate.	—	—
SECONDARY Overall Survival	2.7	—
SECONDARY Progression-free Survival	1.2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00006389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.