Ovarian CancerPhase 2NCT00189566
Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse
A Phase 2 study testing Paclitaxel, Topotecan and Carboplatin in people with Ovarian Cancer and Fallopian Tube Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Malignant Tumor of Peritoneum
- What is being tested?
- Paclitaxel, Topotecan and Carboplatin
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2004to Apr 2009
- 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
- Patients aged > 18
- Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum
- Peritoneal and/or nodes and/or visceral metastases
- Disease in progression under treatment or within 6 months after a first or second platinum-based line
- A period of 3 weeks between last chemotherapy and inclusion
- Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria)
- ECOG performance status < 2
- Life expectancy of at least 12 weeks
Who cannot join
- Previously received weekly administration of paclitaxel chemotherapy
- Involved in a trial within the last 30 days
- Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy
- Prior diagnosis of malignancy
- History of ischemic cardiopathy, congestive heart failure (New York Heart Association [NYHA] > 2), arrhythmia, hypertension, or significant valvulopathy
- Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 2
Show all 12Show fewer
- Bone marrow, renal, or hepatic insufficiency
- Severe active infection or occlusive or sub-occlusive disease
- History of symptomatic brain metastases
- Fertile women not using adequate contraceptive methods
- Pregnant or breast feeding women
- Hypersensitivity to compounds chemically related to paclitaxel, topotecan, or carboplatin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National, Randomized, Phase II Study Comparing Efficacy of Weekly Administration of Paclitaxel in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse
This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse.
Read the detailed description
The main purpose of this research study is to find out if treatment of early relapse of ovarian or fallopian tube or peritoneal cancer with paclitaxel (Taxol*) weekly administered, in lower doses in combination with topotecan (Hycamtin*) or carboplatin will improve efficacy compared to weekly administration of paclitaxel in monotherapy. Tolerance in the three groups will be compared.
- Being tested
- Paclitaxel, Topotecan, Carboplatin
- Keywords
- Relapse within 6 months, Previously received taxane derivative
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
TopotecanDrug
CarboplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival of patients in the three groups
Secondary outcomes (4)
Overall survival
Rate of response and rate of progression at the end of treatment
Qualitative and quantitative toxicities
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2004
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Investigators
- Laure Chauvenet, MD, PhD, Study director, Hôpital Hôtel Dieu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189566
- Sponsor's protocol ID
- CAR\TAXHY
- Status last verified
- Feb 2011
- First submitted
- 12 Sep 2005
- Last updated
- 25 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Randomized, Phase II Study Comparing Efficacy of Weekly Administration of Paclitaxel in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse
- ClinicalTrials.gov ID
- NCT00189566
- Acronym / sponsor ID
- CAR\TAXHY
- Keywords
- Relapse within 6 months, Previously received taxane derivative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Apr 2009 (actual)
- First posted
- 19 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.
This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse.
Detailed description
The main purpose of this research study is to find out if treatment of early relapse of ovarian or fallopian tube or peritoneal cancer with paclitaxel (Taxol*) weekly administered, in lower doses in combination with topotecan (Hycamtin*) or carboplatin will improve efficacy compared to weekly administration of paclitaxel in monotherapy. Tolerance in the three groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Patients aged > 18
- Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum
- Peritoneal and/or nodes and/or visceral metastases
- Disease in progression under treatment or within 6 months after a first or second platinum-based line
- A period of 3 weeks between last chemotherapy and inclusion
Key exclusion criteria (12 listed)
- Previously received weekly administration of paclitaxel chemotherapy
- Involved in a trial within the last 30 days
- Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy
- Prior diagnosis of malignancy
- History of ischemic cardiopathy, congestive heart failure (New York Heart Association [NYHA] > 2), arrhythmia, hypertension, or significant valvulopathy
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 | – |
| Topotecan | Drug | – |
| Carboplatin | Drug | – |
Primary outcome
Progression-free survival of patients in the three groups
4 secondary outcomes
Overall survival
Rate of response and rate of progression at the end of treatment
Qualitative and quantitative toxicities
Quality of life
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 25 Feb 2011.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Laure Chauvenet, MD, PhD study director
Hôpital Hôtel Dieu
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 Paclitaxel, Topotecan and Carboplatin in people with Ovarian Cancer and Fallopian Tube Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
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 12 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 25 Feb 2011. 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 France. 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.
What does the primary outcome measure?
Progression-free survival of patients in the three groups. 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 25 Feb 2011.