Endometrial CancerPhase 2NCT00022620
Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
A Phase 2 study testing paclitaxel in people with Endometrial Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 6 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer. Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- paclitaxel
- How many people
- Not given
- Where
- 8 sitesin 6 countries
- Study dates
- Jun 2001to Oct 2002
- 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 Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma)
- Progressive or recurrent
- Bidimensionally measurable disease
- Platinum refractory disease, defined by one of the following:
- Progression during platinum-based chemotherapy
- Stable disease for at least 4 courses of platinum-based chemotherapy
- Recurrence within 4 months of platinum-based chemotherapy
- No brain involvement or leptomeningeal disease
PATIENT CHARACTERISTICS:
Age:
- 75 and under
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 50 umol/L
Renal:
- BUN no greater than 8.0 mmol/L
- Creatinine no greater than 120 umol/L
- Creatinine clearance at least 60 mL/min
Other:
- Not pregnant
- Fertile patients must use effective contraception
- HIV negative
- No other prior or concurrent malignancy except basal cell carcinoma of the skin
- No active bacterial infection (e.g., urinary tract infection)
- No uncontrolled or potentially active site of infection (e.g., fistula or abscess)
- No psychological, familial, sociological, or geographical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- At least 1 prior platinum containing regimen
- At least 50 mg/m2 per course for a maximum of 28 days for cisplatin
- At least 5 times AUC for a maximum of 4 weeks per course for carboplatin
- Prior non-taxane-containing chemotherapy allowed
Endocrine therapy:
- At least 4 weeks since prior hormonal therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- At least 3 months since prior radiotherapy to target lesion
- Concurrent radiotherapy allowed for bone pain provided evaluable lesions are outside of irradiation field)
Surgery:
- Prior surgical management of lymph nodes allowed
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Belgium2 sites
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
U.Z. Gasthuisberg
Leuven, B-3000
Italy2 sites
Ospedale Mauriziano Umberto I
Torino, 10128
Ospedale Civile
Voghera (PV), 27058
United Kingdom1 site
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX
About this study
Official title: Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer.
Read the detailed description
OBJECTIVES:
- Determine the therapeutic activity of paclitaxel in patients with refractory or recurrent endometrial papillary carcinoma.
- Determine the objective response and duration of response in patients treated with this regimen.
- Determine the acute side effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks.
PROJECTED ACCRUAL: Approximately 16-29 patients will be accrued for this study.
- Conditions
- Endometrial Cancer
- Being tested
- paclitaxel
- Keywords
- recurrent endometrial carcinoma, endometrial papillary serous 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.
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2001
- Primary completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Masking
- None (open label)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gerald Gitsch, MD, Study chair, Allgemeines Krankenhaus - Universitatskliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022620
- Sponsor's protocol ID
- EORTC-55961
- Other IDs
- EORTC-55961
- Status last verified
- Sep 2012
- First submitted
- 10 Aug 2001
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)
- ClinicalTrials.gov ID
- NCT00022620
- Acronym / sponsor ID
- EORTC-55961
- Conditions
- Endometrial Cancer
- Keywords
- recurrent endometrial carcinoma, endometrial papillary serous carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jun 2001
- Primary completion
- Oct 2002 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer.
Detailed description
OBJECTIVES:
- Determine the therapeutic activity of paclitaxel in patients with refractory or recurrent endometrial papillary carcinoma.
- Determine the objective response and duration of response in patients treated with this regimen.
- Determine the acute side effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks.
PROJECTED ACCRUAL: Approximately 16-29 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| paclitaxel | Drug | – |
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 24 Sep 2012.
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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.
Gerald Gitsch, MD study chair
Allgemeines Krankenhaus - Universitatskliniken
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel in people with Endometrial Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 6 countries.
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 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Italy, Austria, Portugal, Spain and 1 more country. 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 24 Sep 2012.