Clinical trial · Interventional
Arsenic Trioxide in Treating Patients With Stage IVB or Recurrent Cervical Cancer
A Phase II Study of Arsenic Trioxide (NSC #706363) in Patients With Advanced Cervical Carcinoma
NCT00005999CI-TRIAL-00010916completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 17 Years
Show eligibility criteria text
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 agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.