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

NCT00006389 | Completed Phase 2 Results

• 7 other identifiers: NCI-2012-02361CHNMC-PHII-22CDR0000068267NCI-T99-0040PHII-22 (USC 3S-00-1)T99-0040N01CM17101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage III Gastric Cancer; Stage IV Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Overall Survival

  18 months

• Progression-free Survival

  18 months

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: bryostatin 1; Drug: cisplatin; Other: laboratory biomarker analysis

Interventions

bryostatin 1 DRUG

Given IV

Also known as: B705008K112, BRYO, Bryostatin

Treatment

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment

laboratory biomarker analysis OTHER

Correlative studies

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033-0804, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

bryostatin 1; Bryostatins; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Polyether Toxins; Polyether Polyketides; Ethers, Cyclic; Ethers; Organic Chemicals; Macrolides; Polyketides; Lactones; Macrocyclic Compounds; Polycyclic Compounds; Marine Toxins; Toxins, Biological; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

Of 12 pts accrued\\treated, none responded. The initial phase accrual goal was 15, but given the 12 non-responders, we determined the probability of 3 future pts all responding (stochastic curtailed sampling) at 2.7%. Decided to terminate the trial.

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• Heinz-Josef Lenz

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2000
• First Posted: January 27, 2003
• Study Start: October 1, 2000
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 1, 2014
• Results First Posted: October 1, 2014

Record last verified: 2013-10

Locations

US (1)