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.

Condition	Treatment or Intervention	Phase
recurrent cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma stage III cervical cancer cervical adenosquamous cell carcinoma stage IVA cervical cancer stage IVB cervical cancer	Drug: bryostatin 1  Drug: bryostatin 1/cisplatin  Drug: cisplatin	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States
      New York Medical College, Valhalla,  New York,  10595,  United States
      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States
      Saint Vincent Catholic Medical Center of New York, New York,  New York,  10011,  United States

Study chairs or principal investigators

Farr Nezhat,  Study Chair,  Mount Sinai Medical Center   

Study ID Numbers:  CDR0000067948; MTS-99-1113-ME; NCI-T99-0082
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005965
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08