NCT00005999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2000

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 21, 2003

Completed
Last Updated

June 21, 2013

Status Verified

March 1, 2002

First QC Date

July 5, 2000

Last Update Submit

June 20, 2013

Conditions

Cervical Cancer

Keywords

recurrent cervical cancerstage IVB cervical cancercervical squamous cell carcinomacervical adenocarcinoma

Interventions

arsenic trioxideDRUG

Eligibility Criteria

Age17 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Carol Aghajanian, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

May 21, 2003

Study Start

April 1, 2000

Study Completion

May 1, 2003

Last Updated

June 21, 2013

Record last verified: 2002-03

Locations

US(1)