Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005965
First received: July 5, 2000
Last updated: July 9, 2013
Last verified: July 2004
  Purpose

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 Intervention Phase
Cervical Cancer
Drug: bryostatin 1
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2000
Study Completion Date: April 2004
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005965

Locations
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Saint Vincent Catholic Medical Center of New York
New York, New York, United States, 10011
New York Medical College
Valhalla, New York, United States, 10595
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Study Chair: Farr R. Nezhat, MD Mount Sinai School of Medicine
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00005965     History of Changes
Other Study ID Numbers: MTS-99-1113-ME, CDR0000067948, NCI-T99-0082
Study First Received: July 5, 2000
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Carcinoma, Adenosquamous
Uterine Cervical Neoplasms
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Bryostatin 1
Cisplatin
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014