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Home > "B" Clinical Trials Conditions > Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix  Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
For Condition: stage 4A cervical cancer,recurrent cervical cancer,cervical squamous cell carcinoma,cervical adenosquamous cell carcinoma,stage 3 cervical cancer,stage 4B cervical cancer,cervical adenocarcinoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Mount Sinai Medical Center
Synopsis: RATIONALE: 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. PURPOSE: Phase II trial to study the effectiveness of bryostatin-1 plus cisplatin in treating patients who have recurrent or advanced cancer of the cervix.
Details: OBJECTIVES: I. Determine the safety and efficacy of bryostatin-1 plus cisplatin in patients with recurrent or advanced carcinoma of the cervix. II. Determine the response rate, progression free interval, and duration of survival of these patients when treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients receive bryostatin-1 IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed until death. PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study over 2-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent or advanced carcinoma of the cervix not amenable to surgery or radiotherapy; Squamous cell OR Adenocarcinoma OR Adenosquamous carcinoma - Measurable disease - Brain metastases treated with surgery or radiotherapy allowed if no residual symptoms or medications (e.g., anticonvulsants, corticosteroids) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Prior neoadjuvant chemosensitization therapy allowed At least 3 weeks since prior chemotherapy (6 weeks since prior mitomycin or nitrosoureas) and recovered; Prior cisplatin therapy allowed; No prior chemotherapy for advanced disease - Endocrine therapy: No concurrent corticosteroids - Radiotherapy: At least 2 weeks since prior radiotherapy and recovered - Surgery: Prior surgery allowed - Other: No concurrent anticonvulsants; No concurrent antiarrhythmic medication --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin greater than 9 g/dL - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); AST/ALT less than 2.5 times ULN - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No severe cardiac dysfunction or arrhythmia - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No concurrent unstable medical illness, infection, or other significant medical problem; No clinically apparent neuropathy, including hearing loss; No psychological, familial, sociological, or geographical conditions that may preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FarrNezhat, Study Chair, Mount Sinai Medical Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
New York Medical College
Valhalla, New York, 10595
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Saint Vincent Catholic Medical Center of New York
New York City, New York, 10011
United States
Additional Information:
Study ID Numbers: CDR0000067948; MTS-99-1113-ME,NCI-T99-0082
Study Start Date: December 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005965
Other Stage 4b Cervical Cancer Studies:
1. Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
2. Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
3. Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
4. Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix
5. Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer
Related Studies:
Other stage 4B cervical cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
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