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Arsenic Trioxide in Treating Patients With Stage IVB or Recurrent Cervical Cancer
This study has been completed.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005999
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have stage IVB or recurrent cervical cancer.


Condition Intervention Phase
Cervical Cancer
Drug: arsenic trioxide
Phase II

MedlinePlus related topics: Arsenic Cancer
Drug Information available for: Arsenic trioxide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Arsenic Trioxide (NSC #706363) in Patients With Advanced Cervical Carcinoma

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

Study Start Date: April 2000
Detailed Description:

OBJECTIVES:

  • Evaluate the efficacy of arsenic trioxide in patients with stage IVB or recurrent cervical carcinoma.
  • Determine the safety of this treatment in these patients.

OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 10-19 months.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IVB or recurrent cervical carcinoma that is not amenable to standard curative therapies

    • Squamous carcinoma OR
    • Adenocarcinoma
  • Measurable disease

    • At least 20 mm by conventional techniques OR
    • At least 10 mm by spiral CT scan
    • Nonmeasurable disease defined as any of the following:

      • Bone disease
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed or followed by imaging techniques
      • Cystic lesions
  • No active brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 17 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Greater than 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • No cardiac arrhythmias, unstable angina, or conduction abnormalities
  • No New York Heart Association class III or IV heart disease or clinical evidence of congestive heart failure
  • Pretreatment QTc less than 500 msec

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 months after study
  • No grade 3 or greater neurologic abnormalities
  • No history of seizures
  • No concurrent uncontrolled active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No more than 2 prior therapies for advanced disease

Chemotherapy:

  • No more than 2 prior therapies for advanced disease
  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • No more than 2 prior therapies for advanced disease

Radiotherapy:

  • No more than 2 prior therapies for advanced disease
  • At least 4 weeks since prior radiotherapy

Surgery:

  • Not specified

Other:

  • At least 4 weeks since prior cytotoxic therapy or investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005999

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Carol Aghajanian, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068003, MSKCC-00018, NCI-30
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005999     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent cervical cancer
stage IVB cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma

Study placed in the following topic categories:
Epidermoid Carcinoma
Arsenic trioxide
Squamous Cell Carcinoma
Adenocarcinoma
Carcinoma, Squamous Cell
Recurrence
Carcinoma

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Arsenic trioxide
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009