AzTrials
AzTrials

Cervical CancerPhase 2NCT00276796

Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

A Phase 2 study testing cisplatin, paclitaxel and topotecan hydrochloride in people with Cervical Cancer, run by Gynecologic Oncology Group.

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, such as paclitaxel, topotecan, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
cisplatin, paclitaxel and topotecan hydrochloride
How many people
66 participants
Where
No sites listed yet
Study dates
Start not givento Jan 2007
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Advanced, persistent, or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression
  • Histologic confirmation of the original primary tumor is required
  • Disease must be measurable in at least one dimension by conventional techniques, including palpation, plain x-ray, CT scan, or MRI
  • Measurable disease is defined as at least one lesion that can be accurately measured
  • Each lesion must be ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiation therapy

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • SGOT and alkaline phosphatase ≤ 2.5 times ULN
  • Neuropathy (sensory and motor) ≤ grade 1
  • No active infection requiring antibiotics
  • No evidence of more than one malignancy present within the past 5 years
  • Nonmelanoma skin cancer allowed
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior therapy with cytotoxic drugs for advanced or recurrent cervical carcinoma
  • Prior cisplatin as a radiosensitizer for primary treatment of disease allowed
  • No previous cancer treatment that contraindicates study treatment
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of cervical cancer
  • No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of cervical cancer
  • Recovered from effects of recent surgery, radiotherapy, or other therapy
  • At least 4 weeks since prior radiotherapy
  • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and free of recurrent or metastatic disease
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer provided patient is free of recurrent or metastatic disease
  • No hormonal therapy directed at the malignant tumor within the past week
  • Concurrent hormone replacement therapy is permitted
  • No concurrent amifostine or other protective reagents

About this study

Official title: A Limited Access Phase II Trial of Weekly Topotecan (NSC #609699), Paclitaxel (NSC #673089), and Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with topotecan and cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Estimate the antitumor activity of the combination of paclitaxel, topotecan, and cisplatin in patients with advanced, persistent, or recurrent carcinoma of the cervix.
  • Determine the nature and degree of toxicity for this drug regimen in these patients.

Secondary

  • Determine the duration of progression-free survival and overall survival.
  • Determine the impact of prior chemoradiation on response to treatment.

OUTLINE: This is an open-label study.

Patients receive paclitaxel IV over 1 hour followed by topotecan IV over 30 minutes and cisplatin IV over 1 hour on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.

Conditions
Cervical Cancer
Being tested
cisplatin, paclitaxel, topotecan hydrochloride
Keywords
cervical squamous cell carcinoma, stage III cervical cancer, recurrent cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical small cell carcinoma, stage IVA cervical cancer, stage IVB cervical cancer
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The frequency and duration of objective response

  2. The frequency and severity of observed adverse effects

Secondary outcomes (2)

  1. Progression-free survival and overall survival

  2. Prognostic factor: prior chemoradiation

Timeline

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

  1. First posted13 Jan 2006 (estimated)
  2. Primary completionJan 2007

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
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00276796
Sponsor's protocol ID
CDR0000456248
Other IDs
GOG-0076EE
Status last verified
Feb 2009
First submitted
12 Jan 2006
Last updated
27 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, paclitaxel and topotecan hydrochloride in people with Cervical Cancer, run by Gynecologic Oncology Group.

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 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.

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.

What does the primary outcome measure?

The frequency and duration of objective response. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00276796.

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 27 May 2013.

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