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

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide

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