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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006389
First Posted: January 27, 2003
Last Update Posted: October 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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.

Condition Intervention Phase
Stage III Gastric Cancer Stage IV Gastric Cancer Drug: bryostatin 1 Drug: cisplatin Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Observed Response Rate. [ Time Frame: Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles. ]

    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.



Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 18 months ]
    Overall survival was estimated according to the Kaplan-Meier product-limit method.

  • Progression-free Survival [ Time Frame: 18 months ]
    Progression-free survival was estimated according to the Kaplan-Meier product-limit method


Enrollment: 12
Study Start Date: October 2000
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006389


Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Heinz-Josef Lenz University of Southern California
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006389     History of Changes
Other Study ID Numbers: NCI-2012-02361
NCI-2012-02361 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CHNMC-PHII-22
CDR0000068267
NCI-T99-0040
PHII-22 (USC 3S-00-1) ( Other Identifier: University of Southern California )
T99-0040 ( Other Identifier: CTEP )
N01CM17101 ( U.S. NIH Grant/Contract )
First Submitted: October 4, 2000
First Posted: January 27, 2003
Results First Submitted: September 26, 2014
Results First Posted: October 1, 2014
Last Update Posted: October 1, 2014
Last Verified: October 2013

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Bryostatin 1
Cisplatin
Antineoplastic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs