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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Mount Sinai Medical Center
Information provided by: National Cancer Institute (NCI)

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 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

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Bryostatin 1 Plus Cisplatin in Patients With Recurrent or Advanced Carcinoma of the Cervix

Further Study Details: 

Study start: December 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.

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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

Location Information


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   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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