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: October 25, 2013
Last verified: October 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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, 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.


Enrollment: 62
Study Start Date: October 2000
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006389

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

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006389     History of Changes
Other Study ID Numbers: NCI-2012-02361, NCI-2012-02361, CHNMC-PHII-22, CDR0000068267, NCI-T99-0040, PHII-22 (USC 3S-00-1), T99-0040, N01CM17101
Study First Received: October 4, 2000
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014