Uterine NeoplasmsPhase 2NCT00782041
Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer
A Phase 2 study testing Oxaliplatin, 5-FluoroUracil and Folinic acid in people with Uterine Neoplasms, run by Sanofi at 1 site in Thailand.
Trial summary
Primary: To assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline. Secondary: To assess the safety and tolerability of oxaliplatin To assess time to progression and overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Neoplasms
- What is being tested?
- Oxaliplatin, 5-FluoroUracil and Folinic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2003to Aug 2003
- 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
- Have Locally advanced/metastatic squamous or adenocarcinoma of the cervix
- Prior therapy with cisplatin allowed
- First-line treatment may have been surgery,radiotherapy or chemotherapy either as a single agent or multi-modality therapy
- Must have measurable disease
- Histologically Proven Carcinoma of the cervix
- ECOG PS ≤2
Show all 9Show fewer
- No other serious concomitant illness
- Fully recovered from any prior therapy
- Lab: ANC >1500 mm³, Platelets > 100000 mm³, Creatinine ≤ 1.5 x Normal value, Bilirubin ≤ 1.5 x Normal value, SGPT (ALT) ≤ 2.5 x Normal value
Who cannot join
- Known allergy to one of the study drugs
- Peripheral neuropathy > grade2
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Oxaliplatin in Combination With 5-fluorouracil (5-FU) and Folinic Acid (FA) in Patients Who Have Failed First-line Treatment for Locally Advanced or Metastatic Cervical Cancer.
Primary:
- To assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline.
Secondary:
- To assess the safety and tolerability of oxaliplatin
- To assess time to progression and overall survival.
- Conditions
- Uterine Neoplasms
- Being tested
- Oxaliplatin, 5-FluoroUracil, Folinic acid
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
85 mg/m²
5-FluoroUracilDrug
2,000 mg/m²
Folinic acidDrug
20 mg/m²
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1. Receives: Drug: Oxaliplatin; Drug: 5-FluoroUracil; Drug: Folinic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: Throughout the study period
Secondary outcomes (3)
Progression-free survival
Measured: Throughout the study period
Overall survival
Measured: Throughout the study period
Adverse events
Measured: Throughout the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startJan 2003
- Primary completionAug 2003
Why it stopped: protocol violation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paibulsirijit Sompob, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782041
- Sponsor's protocol ID
- L_8311
- Status last verified
- Sep 2009
- First submitted
- 28 Oct 2008
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Oxaliplatin in Combination With 5-fluorouracil (5-FU) and Folinic Acid (FA) in Patients Who Have Failed First-line Treatment for Locally Advanced or Metastatic Cervical Cancer.
- ClinicalTrials.gov ID
- NCT00782041
- Acronym / sponsor ID
- L_8311
- Conditions
- Uterine Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: protocol violation
- Enrolment
- 11 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Aug 2003 (actual)
- First posted
- 29 Oct 2008 (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.
Primary:
- To assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline.
Secondary:
- To assess the safety and tolerability of oxaliplatin
- To assess time to progression and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oxaliplatin, Drug: 5-FluoroUracil, Drug: Folinic acidOxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have Locally advanced/metastatic squamous or adenocarcinoma of the cervix
- Prior therapy with cisplatin allowed
- First-line treatment may have been surgery,radiotherapy or chemotherapy either as a single agent or multi-modality therapy
- Must have measurable disease
- Histologically Proven Carcinoma of the cervix
Key exclusion criteria (3 listed)
- Known allergy to one of the study drugs
- Peripheral neuropathy > grade2
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| Oxaliplatin85 mg/m² | Drug | 1 |
| 5-FluoroUracil2,000 mg/m² | Drug | 1 |
| Folinic acid20 mg/m² | Drug | 1 |
Primary outcome
Response rate
Time frame: Throughout the study period
3 secondary outcomes
Progression-free survival
Time frame: Throughout the study period
Overall survival
Time frame: Throughout the study period
Adverse events
Time frame: Throughout the study period
Results and safety
The study was stopped early (reason given: protocol violation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 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.
Paibulsirijit Sompob, MD study director
Sanofi
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 Oxaliplatin, 5-FluoroUracil and Folinic acid in people with Uterine Neoplasms, run by Sanofi at 1 site in Thailand.
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 9 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Sep 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 Thailand. 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 was stopped early (reason given: protocol violation). 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?
Response rate (time frame: Throughout the study period). 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 15 Sep 2009.