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Cervical CancerPhase 1NCT00084890

Docetaxel and Carboplatin in Treating Patients With Recurrent Stage IVB Squamous Cell Carcinoma (Cancer) of the Cervix

A Phase 1 study testing carboplatin and docetaxel in people with Cervical Cancer, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining docetaxel with carboplatin may kill more 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?
carboplatin and docetaxel
Type of treatment
Injection or infusion
How many people
15 participants
Where
1 siteUnited States
Study dates
Nov 2003to Apr 2010
Phase
Phase 1
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 confirmed squamous cell carcinoma of the uterine cervix
  • Advanced disease (stage IVB)
  • Persistent or recurrent disease
  • No available curative treatment options
  • Measurable disease by physical examination, chest x-ray, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • GOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 8 g/dL

Hepatic

  • Bilirubin normal
  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR
  • Alkaline phosphatase ≤ 4 times ULN AND SGOT and SGPT normal

Renal

  • Creatinine < 1.5 times ULN

Other

  • No other invasive malignancy within the past 5 years
  • No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No peripheral neuropathy > grade 1
  • No other concurrent malignancy except curatively treated non-melanoma skin cancer
  • No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic therapy

Chemotherapy

  • No more than 2 prior chemotherapy regimens
  • One sensitizing chemotherapy regimen during radiotherapy AND 1 regimen for recurrent disease are considered 2 regimens
  • At least 4 weeks since prior chemotherapy
  • No prior docetaxel
  • No prior carboplatin
  • No other concurrent chemotherapy

Endocrine therapy

  • At least 4 weeks since prior hormonal therapy

Radiotherapy

  • See Chemotherapy
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • At least 3 weeks since prior major surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1065

Other trials in United States

About this study

Official title: Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining docetaxel with carboplatin 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 carboplatin and to see how well they work in treating patients with recurrent stage IVB squamous cell carcinoma (cancer) of the cervix.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of docetaxel when administered with carboplatin in patients with recurrent stage IVB squamous cell carcinoma of the cervix.
  • Determine the response rate and time to progression in patients treated with this regimen.

Secondary

  • Determine the toxicity of this regimen in these patients.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is phase I, dose-escalation study of docetaxel followed by a phase II study.

  • Phase I: Patients receive docetaxel IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate continuing tumor shrinkage after 6 courses receive 2 additional courses beyond their best response.

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.

  • Phase II: Patients receive docetaxel and carboplatin as in phase I at the MTD determined in phase I.

Quality of life is assessed at baseline, before every other course of treatment, and at the end of study treatment.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 16-40 for phase II) will be accrued for this study within 2 years.

Conditions
Cervical Cancer
Being tested
carboplatin, docetaxel
Keywords
stage IVB cervical cancer, recurrent cervical cancer, cervical squamous cell carcinoma
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.

  • carboplatinDrug

    30 minute infusion dosed based on glomerular filtration rate of patient

  • docetaxelDrug

    escalating doses ofstarting at 25 milligrams per meter squared

What is being measured

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

  1. Maximum tolerated dose of docetaxel

    Measured: 28 days

Timeline

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

  1. First posted11 Jun 2004 (estimated)
  2. Study startNov 2003
  3. Primary completionMar 2007
  4. Study completionApr 2010

Why it stopped: slow accrual

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00084890
Sponsor's protocol ID
CDR0000366942
Other IDs
CCCWFU-30102B, NCI-6949
Status last verified
Aug 2018
First submitted
10 Jun 2004
Last updated
10 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing carboplatin and docetaxel in people with Cervical Cancer, run by Wake Forest University Health Sciences 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: stopped early, as of the sponsor's last update on 10 Aug 2018. 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 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.

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 stopped early (reason given: slow accrual). Results are not available in the source record.

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?

Maximum tolerated dose of docetaxel (time frame: 28 days). 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 NCT00084890.

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 10 Aug 2018.

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