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

Cervical Cancer Clinical Trial

Official title:

A Phase II Study of Arsenic Trioxide (NSC #706363) in Patients With Advanced Cervical Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005999
• Other study ID #: CDR0000068003
• Secondary ID: MSKCC-00018NCI-3
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: June 20, 2013
• Start date: April 2000
• Est. completion date: May 2003

Study information

• Verified date: March 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• arsenic trioxide

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,