search
Back to results

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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
arsenic trioxide
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
June 20, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00005999
Brief Title
Arsenic Trioxide in Treating Patients With Stage IVB or Recurrent Cervical Cancer
Official Title
A Phase II Study of Arsenic Trioxide (NSC #706363) in Patients With Advanced Cervical Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2002
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
arsenic trioxide

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Aghajanian, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs