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Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer
This study is ongoing, but not recruiting participants.
First Received: October 4, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Norris Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006389
  Purpose

RATIONALE: 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.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer.


Condition Intervention Phase
Gastric Cancer
Drug: bryostatin 1
Drug: cisplatin
Phase II

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Cisplatin Bryostatin 1
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Combination Trial of Bryostatin-1 and Cisplatin in the Treatment of Metastatic Gastric Cancer

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

Study Start Date: November 2000
Detailed Description:

OBJECTIVES:

  • Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin.
  • Determine the toxic effects of this regimen in these patients.
  • 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.

PROJECTED ACCRUAL: A total of 15-62 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic or unresectable carcinoma of the stomach
  • Measurable disease
  • No brain metastasis

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 3 months

Hematopoietic:

  • 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

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 2 times normal

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • More than 4 weeks since prior major surgery
  • Prior incomplete resection allowed

Other:

  • No other prior antitumor treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006389

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
Norris Comprehensive Cancer Center
Investigators
Study Chair: Heinz-Josef Lenz, MD Norris Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068267, LAC-USC-3S001, CHNMC-PHII-22, NCI-T99-0040
Study First Received: October 4, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006389     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III gastric cancer
stage IV gastric cancer

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Immunologic Factors
Radiation-Sensitizing Agents
Cisplatin
Gastrointestinal Diseases
Stomach Neoplasms
Adjuvants, Immunologic
Gastrointestinal Neoplasms
Bryostatin 1
Stomach Cancer

Additional relevant MeSH terms:
Digestive System Neoplasms
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Bryostatin 1
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Stomach Diseases
Radiation-Sensitizing Agents
Cisplatin
Stomach Neoplasms
Therapeutic Uses
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009