|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Mount Sinai School of Medicine National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005965 |
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 II |
| Study Type: | Interventional |
| Study Design: | 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 |
| Study Start Date: | August 2000 |
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 |
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| 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 Medical College | |
| Valhalla, New York, United States, 10595 | |
| Saint Vincent Catholic Medical Center of New York | |
| New York, New York, United States, 10011 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| New York Presbyterian Hospital - Cornell Campus | |
| New York, New York, United States, 10021 | |
| Study Chair: | Farr R. Nezhat, MD | Mount Sinai School of Medicine |
More Information
| Study ID Numbers: | CDR0000067948, MTS-99-1113-ME, NCI-T99-0082 |
| Study First Received: | July 5, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005965 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Immunologic Factors Adjuvants, Immunologic Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Bryostatin 1 Squamous Cell Carcinoma Recurrence Carcinoma Uterine Cervical Neoplasms |
Genital Diseases, Female Uterine Cervical Diseases Radiation-Sensitizing Agents Cisplatin Epidermoid Carcinoma Uterine Neoplasms Carcinoma, Squamous Cell Adenocarcinoma Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Bryostatin 1 Pharmacologic Actions Carcinoma Uterine Cervical Neoplasms |
Genital Diseases, Female Neoplasms Uterine Cervical Diseases Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Uterine Neoplasms Carcinoma, Adenosquamous Neoplasms, Complex and Mixed Neoplasms, Glandular and Epithelial |