Arsenic Trioxide in Treating Patients With Stage IVB or Recurrent Cervical Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005999
First received: July 5, 2000
Last updated: June 20, 2013
Last verified: March 2002
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Arsenic Trioxide (NSC #706363) in Patients With Advanced Cervical Carcinoma

Resource links provided by NLM:


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

Study Start Date: April 2000
Study Completion Date: May 2003
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00005999     History of Changes
Other Study ID Numbers: CDR0000068003, MSKCC-00018, NCI-30
Study First Received: July 5, 2000
Last Updated: June 20, 2013
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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014