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


Phase 2
17 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Carol Aghajanian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068003

NCT ID:

NCT00005999

Start Date:

April 2000

Completion Date:

May 2003

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • Uterine Cervical Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021