Endometrial CancerPhase 2NCT00258362
Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer
A Phase 2 study testing carboplatin, docetaxel and radiation therapy in people with Endometrial Cancer, run by Masonic Cancer Center, University of Minnesota at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, 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
- Endometrial Cancer
- What is being tested?
- carboplatin, docetaxel and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed endometrial cancer
- Advanced or recurrent disease
- Stage IIIB or IIIC disease
- Stage IIIA disease allowed provided there is serosal involvement or direct extension or metastasis to the adnexa
- No stage IIIA confirmed by only positive peritoneal washings
- Stage IVA or IVB disease
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- Failed local therapy or considered incurable with local therapy
- Measurable or evaluable disease
- Not required for newly diagnosed stage III or IV disease with no remaining disease after surgery
- Performance status Gynecology Oncology Group (GOG) 0-1
- Life expectancy at least 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
- Bilirubin normal
- No acute hepatitis
- Creatinine ≤ 1.5 mg/dL
Who cannot join
- Known hypersensitivity to docetaxel or polysorbate 80
- Severe infection
- Septicemia
- Pregnant or nursing
- Positive pregnancy test
- Fertile patients must use effective nonhormonal contraception during and for at least 3 months after study treatment
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- Peripheral neuropathy ≥ grade 2
- Severe gastrointestinal bleeding requiring a blood transfusion or hospitalization
- Other malignancy within the past 5 years except nonmetastatic, nonmelanoma skin cancer or carcinoma in situ of the cervix
- Prior chemotherapy
- Prior radiotherapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55426
About this study
Official title: A Phase II Trial of Induction Carboplatin and Docetaxel Followed by Radiotherapy Then Consolidation Chemotherapy With Carboplatin and Docetaxel in Stage III, IV and Recurrent Endometrial Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III, stage IV, or recurrent endometrial cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel.
Secondary
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: Patients receive docetaxel intravenous (IV) over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses. After hematologic recovery from chemotherapy, patients receive radiotherapy 5 days a week for up to 7 weeks. Beginning 3-4 weeks later, patients receive another 3 courses of docetaxel and carboplatin.
After completion of study treatment, patients are followed periodically for 2 years.
- Conditions
- Endometrial Cancer
- Being tested
- carboplatin, docetaxel, radiation therapy
- Keywords
- recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Also called Gemzar(R)
Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles.
docetaxelDrug
Also called Taxotere(R)
75 mg/m^2 on Day 1 of each course
radiation therapyRadiation
Also called radiation
Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)
| Study group | Role | What they receive |
|---|---|---|
| Patients with Endometrial Cancer | Experimental | Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles). Receives: Drug: carboplatin; Drug: docetaxel; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients Estimated to be Progression-Free and Alive
This estimate was determined by using a statistical method of analysis (Kaplan-Meier).
Measured: 1 Year, 2 Years, 3 Years
Secondary outcomes (1)
Percent of Patients Estimated to be Alive
This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.
Measured: 1 Year, 2 Years, 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Melissa A. Geller, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258362
- Sponsor's protocol ID
- 2004LS021
- Other IDs
- UMN-WCC-38, 13062
- Status last verified
- Dec 2017
- First submitted
- 22 Nov 2005
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Induction Carboplatin and Docetaxel Followed by Radiotherapy Then Consolidation Chemotherapy With Carboplatin and Docetaxel in Stage III, IV and Recurrent Endometrial Cancer
- ClinicalTrials.gov ID
- NCT00258362
- Acronym / sponsor ID
- 2004LS021
- Conditions
- Endometrial Cancer
- Keywords
- recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jul 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Nov 2005 (estimated)
- Results
- Posted 11 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III, stage IV, or recurrent endometrial cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel.
Secondary
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: Patients receive docetaxel intravenous (IV) over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses. After hematologic recovery from chemotherapy, patients receive radiotherapy 5 days a week for up to 7 weeks. Beginning 3-4 weeks later, patients receive another 3 courses of docetaxel and carboplatin.
After completion of study treatment, patients are followed periodically for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Endometrial Cancer | Experimental | Drug: carboplatin, Drug: docetaxel, Radiation: radiation therapyPatients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically confirmed endometrial cancer
- Advanced or recurrent disease
- Failed local therapy or considered incurable with local therapy
- Measurable or evaluable disease
- Performance status Gynecology Oncology Group (GOG) 0-1
Key exclusion criteria (11 listed)
- Known hypersensitivity to docetaxel or polysorbate 80
- Severe infection
- Septicemia
- Pregnant or nursing
- Positive pregnancy test
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 |
|---|---|---|
| carboplatinAlso: Gemzar(R)Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles. | Drug | Patients with Endometrial Cancer |
| docetaxelAlso: Taxotere(R)75 mg/m^2 on Day 1 of each course | Drug | Patients with Endometrial Cancer |
| radiation therapyAlso: radiationWeekly, 5 days/week over 6-7 weeks (tailored 4500 cGy) | Radiation | Patients with Endometrial Cancer |
Primary outcome
Percent of Patients Estimated to be Progression-Free and Alive
Time frame: 1 Year, 2 Years, 3 Years
This estimate was determined by using a statistical method of analysis (Kaplan-Meier).
1 secondary outcome
Percent of Patients Estimated to be Alive
Time frame: 1 Year, 2 Years, 3 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Melissa A. Geller, MD principal investigator
Masonic Cancer Center, University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, docetaxel and radiation therapy in people with Endometrial Cancer, run by Masonic Cancer Center, University of Minnesota at 2 sites 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 21 inclusion and 11 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 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 11 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Patients Estimated to be Progression-Free and Alive (time frame: 1 Year, 2 Years, 3 Years). It is what the study was designed to measure, not a finding.
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 28 Dec 2017.