Cervix NeoplasmPhase 2NCT00178269
Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
A Phase 2 study testing docetaxel and Radiation Therapy in people with Cervix Neoplasm, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to find out how effectively cervix cancer is controlled when radiation is combined with low-dose chemotherapy (Taxotere) . The use of low-dose Taxotere, once per week, with radiation is a new treatment for cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Neoplasm
- What is being tested?
- docetaxel and Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2006
- 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
Who may be able to join
- Histologic confirmation of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix including FIGO (International Federation of Gynecologists and Obstetricians) stage IB to IVA with or without pelvic adenopathy.
- No evidence of para-aortic or distant metastases. Must have evaluable disease.
- Zubrod Performance Status 0-2 or Karnofsky Performance Status > 60
- Laboratory values must be as follows:
- White blood cell count: > 3,000/mm3,Absolute granulocyte count: > 1,500/mm3, Hemoglobin > 8.0 g/dl, Platelets: > 100,000/mm3, Serum creatinine: < 2.5 mg/dl, Serum calcium: < 1.3 x institutional upper normal limit,Hepatic criteria as follows: Total Bilirubin < ULN for the institution,
- Signed study-specific informed consent p
- Age > 18 years.
- Peripheral neuropathy must be < grade 1.
Who cannot join
- Prior or simultaneous malignancies (other than skin cancer) unless disease-free
- Medical illness preventing the use of taxane-based chemotherapy.
- Carcinoma of the cervix with the following histology: melanoma, sarcoma, small carcinoid, glassy cell, clear cell, and adenoid cystic.
- Previous or current medical or psychiatric illness that would prevent informed consent
- Patients known to be infected with HIV or a history of AIDS are excluded.
- Prior surgery for carcinoma of the cervix other than a biopsy.
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- Patients with para-aortic disease.
- Previous pelvic radiation therapy or systemic chemotherapy is not permitted.
- Women who are pregnant or breast-feeding are excluded from this study.
- Previous history of hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 must be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester, Dept. Radiation Oncology
Rochester, New York, 14642
About this study
Official title: A Phase Ii Clinical Study Using Weekly Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
The purpose of this study is to find out how effectively cervix cancer is controlled when radiation is combined with low-dose chemotherapy (Taxotere) . The use of low-dose Taxotere, once per week, with radiation is a new treatment for cervical cancer. This study will also see how well this treatment regimen can be tolerated.
- Conditions
- Cervix Neoplasm
- Being tested
- docetaxel, Radiation Therapy
- 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
Radiation TherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix NeoplasmStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Investigators
- Yuhchyau Chen, MD, Ph.D, Principal investigator, Universtiy of Rochester, Dept of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178269
- Sponsor's protocol ID
- URCC 1328
- Status last verified
- May 2009
- First submitted
- 12 Sep 2005
- Last updated
- 19 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ii Clinical Study Using Weekly Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
- ClinicalTrials.gov ID
- NCT00178269
- Acronym / sponsor ID
- URCC 1328
- Conditions
- Cervix Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out how effectively cervix cancer is controlled when radiation is combined with low-dose chemotherapy (Taxotere) . The use of low-dose Taxotere, once per week, with radiation is a new treatment for cervical cancer. This study will also see how well this treatment regimen can be tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologic confirmation of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix including FIGO (International Federation of Gynecologists and Obstetricians) stage IB to IVA with or without pelvic adenopathy.
- No evidence of para-aortic or distant metastases. Must have evaluable disease.
- Zubrod Performance Status 0-2 or Karnofsky Performance Status > 60
- Laboratory values must be as follows:
- White blood cell count: > 3,000/mm3,Absolute granulocyte count: > 1,500/mm3, Hemoglobin > 8.0 g/dl, Platelets: > 100,000/mm3, Serum creatinine: < 2.5 mg/dl, Serum calcium: < 1.3 x institutional upper normal limit,Hepatic criteria as follows: Total Bilirubin < ULN for the institution,
Key exclusion criteria (10 listed)
- Prior or simultaneous malignancies (other than skin cancer) unless disease-free
- Medical illness preventing the use of taxane-based chemotherapy.
- Carcinoma of the cervix with the following histology: melanoma, sarcoma, small carcinoid, glassy cell, clear cell, and adenoid cystic.
- Previous or current medical or psychiatric illness that would prevent informed consent
- Patients known to be infected with HIV or a history of AIDS are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | – |
| Radiation Therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuhchyau Chen, MD, Ph.D principal investigator
Universtiy of Rochester, Dept of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and Radiation Therapy in people with Cervix Neoplasm, run by University of Rochester 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?
The sponsor lists 8 inclusion and 10 exclusion criteria. 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 19 May 2009. 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?
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 19 May 2009.