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

NCT ID: NCT00005999

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30
• Study Completion Date: 2003-05-31

Brief 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.

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.

Conditions

Cervical Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

arsenic trioxide

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 17 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Carol Aghajanian, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-00018

Identifier Type: -

Identifier Source: secondary_id

NCI-30

Identifier Type: -

Identifier Source: secondary_id

CDR0000068003

Identifier Type: -

Identifier Source: org_study_id