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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: arsenic trioxide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00005999

NCI-30

CDR0000068003

MSKCC-00018

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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