Bryostatin 1 and Cisplatin in Treating Patients With Advanced Recurrent or Residual Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006942
First received: December 6, 2000
Last updated: December 19, 2012
Last verified: December 2012
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Purpose
Phase II trial to study the effectiveness of combining bryostatin 1 and cisplatin in treating patients who have advanced recurrent or residual ovarian epithelial, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer Stage III Ovarian Epithelial Cancer Stage IV Ovarian Epithelial Cancer |
Drug: bryostatin 1 Drug: cisplatin Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Bryostatin in Combination With Cisplatin in Patients With Recurrent or Persistent Epithelial Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival [ Time Frame: Time from first day of treatment to time of death due to any cause, assessed up to 9 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Time from first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 9 years ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Time from first day of treatment to the first observation of disease progression or death due to disease, assessed up to 9 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate (CR or PR) [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]Exact 95% confidence intervals will be calculated.
- Time to treatment failure [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]Estimated using the product-limit method of Kaplan and Meier.
- Duration of response [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]Estimated using the product-limit method of Kaplan and Meier.
- Incidence by severity and type of toxicity based on the National Cancer Institute (NCI) Common Toxicity Criteria v2.0 and NCI Myalgia Toxicity Grading Scale [ Time Frame: Up to 9 years ] [ Designated as safety issue: Yes ]
- Association between p53, p21, bcl-2, bax, bcl-2/bax, ERCC-1, and Tdt and tumor response to chemotherapy (CR/PR vs not) [ Time Frame: Prior to initiation of chemotherapy ] [ Designated as safety issue: No ]Proportions and Fisher's exact test will be used. Medians, ranges, quartiles and the Wilcoxon two-sample test will be used.
- Association between p53, p21, bcl-2, bax, bcl-2/bax, ERCC-1, and Tdt and tumor response to chemotherapy (CR/PR vs not) [ Time Frame: Day 5 of course 2 ] [ Designated as safety issue: No ]Proportions and Fisher's exact test will be used. Medians, ranges, quartiles and the Wilcoxon two-sample test will be used.
| Enrollment: | 32 |
| Study Start Date: | October 2000 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (bryostatin 1, cisplatin)
Patients receive bryostatin 1 IV continuously over 72 hours immediately followed by cisplatin IV over 1 hour. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression.
|
Drug: bryostatin 1
Given IV
Other Names:
Drug: cisplatin
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To estimate the overall response rate and the complete response rate of patients with platinum-refractory ovarian cancer who are treated with infusional Bryostatin-1 given in combination with intravenous cisplatin.
II. To estimate the duration of response in these patients. III. To obtain tissue in order to evaluate the molecular determinants of apoptosis including: p53 status, WAF1/CIP1 gene expression prior to and directly after chemotherapy, bcl-2 gene expression in vivo, bcl-2/bax ratio, p21, and the extent of apoptosis determined by the TdT assay; and the molecular determinants of DNA damage and repair including: expression levels of ERCC1.
OUTLINE: This is a multicenter study.
Patients receive bryostatin 1 IV continuously over 72 hours immediately followed by cisplatin IV over 1 hour. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Advanced recurrent or residual ovarian, fallopian tube, or papillary primary peritoneal cancer which has been histologically confirmed
- Eligible patients include patients with measurable disease who have progressed while on chemotherapeutic treatment, patients with biopsy-proven persistent, clinically-measurable disease with best response as stable at the completion of planned first-line therapy, patients with persistent or recurrent disease with rising CA-125 to levels at least twice normal; the CA-125 increase must be documented by two independent measurements; no patient may have received more than two prior regimens of chemotherapy including first-line treatment
- Patients must have a Karnofsky performance status of greater than or equal to 50% and an estimated survival of at least three months
- Measured or calculated clearance >= 60 ml/min
- AGC >= 1800/mm^3
- Plts >= 100,000/mm^3
- Bilirubin =< 1.5 mg/dl
- SGOT less than 2 x upper limit of normal
- Previous radiotherapy or chemotherapy must have been completed at least three weeks before treatment under this protocol
- Patients must have the ability to give voluntary informed consent and to comply with the treatment and required tests
- Because Bryostatin is of unknown teratogenic potential, women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment
- Patients with any non-malignant intercurrent illness (e.g. cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment, or is of such severity that the investigators deem it unwise to enter the patient on protocol shall be ineligible
- Patients currently being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
- The extent of all evaluable and nonevaluable disease must be documented; pretreatment radiographic examinations should be done no earlier than 4 weeks (28 days) prior to the first course of chemotherapy; pre-treatment chemistries and CA-125 levels should be done no earlier than two weeks (14 days) prior to initiation of chemotherapy; (in calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines)
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006942 History of Changes |
| Other Study ID Numbers: | NCI-2012-02831, PHII-21, N01CM17101, CDR0000068346 |
| Study First Received: | December 6, 2000 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Ovarian Neoplasms Abdominal Neoplasms Neoplasms by Site Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Genital Neoplasms, Female Urogenital Neoplasms Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female |
Neoplasms by Histologic Type Endocrine Gland Neoplasms Ovarian Diseases Endocrine System Diseases Gonadal Disorders 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 23, 2013