Clinical trial NCT00005999: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: recurrent cervical cancer
stage IVB cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-05-21
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Carol Aghajanian, MD
role: STUDY_CHAIR
References: