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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Farr R. Nezhat, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000067948

NCT ID:

NCT00005965

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Cervical Cancer
  • 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
  • Uterine Cervical Neoplasms
  • Carcinoma, Adenosquamous

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
New York Medical CollegeValhalla, New York  10595
Saint Vincent Catholic Medical Center of New YorkNew York, New York  10011