Clinical trial NCT00005965: Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
Official title: Phase II Clinical Trial of Bryostatin-1, NSC 339555, and Cisplatin in Patients With Recurrent and/or Advanced Inoperable Squamous Cell, Adeno or Adenosquamous Cell Carcinoma of the Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: stage III cervical cancer
recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-03-05
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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 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)

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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Saint Vincent Catholic Medical Center of New York
state: New York
city: New York
country: United States
facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell Campus
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center, NY
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Farr R. Nezhat, MD
role: STUDY_CHAIR
References:
citation: Nezhat F, Wadler S, Muggia F, Mandeli J, Goldberg G, Rahaman J, Runowicz C, Murgo AJ, Gardner GJ. Phase II trial of the combination of bryostatin-1 and cisplatin in advanced or recurrent carcinoma of the cervix: a New York Gynecologic Oncology Group study. Gynecol Oncol. 2004 Apr;93(1):144-8. doi: 10.1016/j.ygyno.2003.12.021.