Ovarian CancerPhase 1/2NCT00075543
Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
A Phase 1/2 study testing docetaxel and oxaliplatin in people with Ovarian Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 5 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- docetaxel and oxaliplatin
- How many people
- Not given
- Where
- 5 sitesFrance
- Study dates
- Jul 2003to not given
- Phase
- Phase 1/2
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial cancer
- Stage III or IV disease
- Metastatic peritoneal, lymphatic, or visceral disease
- Measurable or evaluable disease
- Previously untreated disease OR relapsed disease more than 6 months after the completion of a platinum-containing chemotherapy regimen
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- WHO 0-2 (0 in patients 70 to 75 years of age)
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- AST and ALT no greater than 3 times ULN
- Alkaline phosphatase less than 2.5 times ULN
Renal
- Creatinine no greater than 1.4 mg/dL
Other
- No serious uncontrolled infection
- No intolerance to polysorbate 80
- No peripheral neuropathy greater than grade 1
- No neurological or mental disease that would preclude study participation
- No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
- No more than 1 prior chemotherapy regimen
- No prior oxaliplatin or docetaxel
Endocrine therapy
- Not specified
Radiotherapy
- More than 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- More than 28 days since prior participation in another clinical study
- No other concurrent anticancer treatment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Intercommunal Hospital
Montfermeil, 93370
Hopital Saint Antoine
Paris, 75012
Hopital Tenon
Paris, 75970
Polyclinique De Courlancy
Reims, F-51100
C.H. Senlis
Senlis, 60309
About this study
Official title: Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and oxaliplatin and to see how well they work in treating patients with stage III or stage IV ovarian epithelial cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with stage III or IV ovarian epithelial cancer.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine the tolerance profile of patients treated with this regimen.
- Determine a recommended phase III dose of this regimen in these patients.
- Determine the efficacy of this regimen, in terms of objective response rate and radiological and biological response rate (CA 125), in these patients.
- Determine the complete pathological response in patients treated with this regimen as first-line therapy.
- Determine the duration of the objective response in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months.
PROJECTED ACCRUAL: A total of 30-39 patients will be accrued for this study.
- Conditions
- Ovarian Cancer
- Being tested
- docetaxel, oxaliplatin
- Keywords
- recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
oxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of docetaxel and oxaliplatin
Toxicity
Secondary outcomes (6)
Tolerance profile
Recommended phase III dose
Efficacy
Complete pathological response
Duration of the objective response
Time to progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2004 (estimated)
- Study startJul 2003
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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Investigators
- Christophe Tournigand, Study chair, Hopital Saint Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075543
- Sponsor's protocol ID
- CDR0000346887
- Other IDs
- FRE-GERCOR-DOCELOX/O-01-1, EU-20332
- Status last verified
- Jul 2007
- First submitted
- 9 Jan 2004
- Last updated
- 24 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
- ClinicalTrials.gov ID
- NCT00075543
- Acronym / sponsor ID
- CDR0000346887
- Conditions
- Ovarian Cancer
- Keywords
- recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Jul 2003
- First posted
- 12 Jan 2004 (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, such as docetaxel and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and oxaliplatin and to see how well they work in treating patients with stage III or stage IV ovarian epithelial cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with stage III or IV ovarian epithelial cancer.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine the tolerance profile of patients treated with this regimen.
- Determine a recommended phase III dose of this regimen in these patients.
- Determine the efficacy of this regimen, in terms of objective response rate and radiological and biological response rate (CA 125), in these patients.
- Determine the complete pathological response in patients treated with this regimen as first-line therapy.
- Determine the duration of the objective response in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months.
PROJECTED ACCRUAL: A total of 30-39 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| docetaxel | Drug | – |
| oxaliplatin | Drug | – |
Primary outcome
Maximum tolerated dose of docetaxel and oxaliplatin
Toxicity
6 secondary outcomes
Tolerance profile
Recommended phase III dose
Efficacy
Complete pathological response
Duration of the objective response
Time to progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2008.
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.
Christophe Tournigand study chair
Hopital Saint Antoine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing docetaxel and oxaliplatin in people with Ovarian Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 5 sites in France.
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: status not confirmed, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined 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.
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?
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 and oxaliplatin. The study lists 2 primary outcomes in all. 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 24 Jul 2008.