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
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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:
Drug: cisplatin
Given IV
Other Names:
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
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, LAC-USC-3S001, N01CM17101, CDR0000068267 |
| Study First Received: | October 4, 2000 |
| Last Updated: | January 24, 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 Physiological Effects of Drugs Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 19, 2013