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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006389
First received: October 4, 2000
Last updated: January 24, 2013
Last verified: January 2013
History of Changes

October 4, 2000
January 24, 2013
October 2000
March 2010   (final data collection date for primary outcome measure)
  • Observed response rate, calculated as the percent of evaluable patients whose best response is a CR or PR [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
    Associated exact 95% confidence intervals will be calculated.
  • Time to treatment failure [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
    Will be estimated using the product-limit method of Kaplan and Meier.
  • Duration of response [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
    Will be estimated using the product-limit method of Kaplan and Meier.
  • Survival [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
    Will be estimated using the product-limit method of Kaplan and Meier.
  • Incidence of adverse events [ Time Frame: Up to 9 years ] [ Designated as safety issue: Yes ]
    Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probably association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity.
Not Provided
Complete list of historical versions of study NCT00006389 on ClinicalTrials.gov Archive Site
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Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer
A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer

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

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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage III Gastric Cancer
  • Stage IV Gastric Cancer
  • Drug: bryostatin 1
    Given IV
    Other Names:
    • B705008K112
    • BRYO
    • Bryostatin
  • Drug: cisplatin
    Given IV
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment
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.
Interventions:
  • Drug: bryostatin 1
  • Drug: cisplatin
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
Not Provided
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006389
NCI-2012-02361, LAC-USC-3S001, N01CM17101, CDR0000068267
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Heinz-Josef Lenz University of Southern California
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP