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Cervical CancerPhase 1/2NCT00452920

Docetaxel and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer

A Phase 1/2 study testing docetaxel, cesium Cs 137 and radiation therapy in people with Cervical Cancer, run by University of Miami at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
docetaxel, cesium Cs 137 and radiation therapy
Type of treatment
Surgery or procedure
How many people
0 participants
Where
1 siteUnited States
Study dates
Sep 2003to Jun 2009
Phase
Phase 1/2
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 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma of the uterine cervix
  • Locally advanced (stage IIB- IVA) disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • WBC ≥ 3,000/mm^3
  • Creatinine normal
  • Bilirubin normal
  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) ≤ ULN OR AP ≤ 4 times ULN if SGOT and SGPT ≤ ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment
  • No history of severe allergic reactions to agents containing polysorbate 80
  • No concurrent uncontrolled illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situations that would preclude compliance with study requirements
  • No peripheral neuropathy ≥ grade 2
  • No HIV positivity

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior unrelated therapy and recovered
  • No prior chemotherapy or pelvic radiotherapy
  • No other concurrent investigational agents or anticancer agents or therapies

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Phase I/II Study of Docetaxel as a Radiosensitizer for Locally Advanced Cervical Cancer (GIA 13026)

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients with stage II, stage III, or stage IV cervical cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the recommended phase II dose (RPTD) of docetaxel when administered with radiotherapy in patients with stage IIB-IVA cervical cancer. (Phase I)
  • Assess the progression-free survival of patients treated with this regimen. (Phase II)

Secondary

  • Determine the safety, feasibility, and toxicity of this regimen in these patients. (Phase I)
  • Assess the toxicity of this regimen at the RPTD in these patients. (Phase II)
  • Determine the response in patients treated with this regimen. (Phase II)

OUTLINE: This is a phase I, nonrandomized, prospective, dose-escalation study of docetaxel followed by an open-label phase II study.

  • Phase I: Patients receive docetaxel IV over 30 minutes on day 1. Treatment repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent pelvic external-beam radiotherapy (EBRT) once daily 5 days a week for 5 weeks. Beginning 1-2 weeks after completion of EBRT, patients receive one or two applications of intracavitary low-dose-rate brachytherapy (LDR BT) comprising cesium-137.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose (RPTD) is the dose below the MTD.

  • Phase II: Patients receive docetaxel at the RPTD, EBRT, and LDR BT as in phase I.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.

Conditions
Cervical Cancer
Being tested
docetaxel, cesium Cs 137, radiation therapy
Keywords
cervical squamous cell carcinoma, stage IIB cervical cancer, stage III cervical cancer, stage IVA 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.

  • docetaxelDrug

  • cesium Cs 137Radiation

  • radiation therapyRadiation

What is being measured

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

  1. Recommended phase II dose (Phase I)

  2. Progression-free survival (Phase II)

Secondary outcomes (2)

  1. Response (Phase II)

  2. Toxicity (Phase II)

Timeline

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

  1. First posted28 Mar 2007 (estimated)
  2. Study startSep 2003
  3. Primary completionJun 2009
  4. Study completionJun 2009

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00452920
Sponsor's protocol ID
20020358
Other IDs
SCCC-2002058, WIRB-20050719
Status last verified
Dec 2016
First submitted
27 Mar 2007
Last updated
15 Dec 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing docetaxel, cesium Cs 137 and radiation therapy in people with Cervical Cancer, run by University of Miami 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: withdrawn, as of the sponsor's last update on 15 Dec 2016. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

Recommended phase II dose (Phase I). 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 NCT00452920.

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 15 Dec 2016.

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