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Cervical CancerPhase 2NCT00005999

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

A Phase 2 study testing arsenic trioxide in people with Cervical Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
arsenic trioxide
How many people
Not given
Where
1 siteUnited States
Study dates
Apr 2000to May 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Cervical Cancer
Being tested
arsenic trioxide
Keywords
recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arsenic trioxideDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2003 (estimated)
  2. Study startApr 2000
  3. Study completionMay 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005999
Sponsor's protocol ID
CDR0000068003
Other IDs
MSKCC-00018, NCI-30
Status last verified
Mar 2002
First submitted
5 Jul 2000
Last updated
21 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing arsenic trioxide in people with Cervical Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.

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