Colorectal NeoplasmsPhase 2NCT00988897
Colorectal Cancer RECHALLENGE
A Phase 2 study testing OXALIPLATIN (SR96669), 5-FLUOROURACIL (5-FU) and LEUCOVORIN (LV) in people with Colorectal Neoplasms, run by Sanofi at 1 site in Canada.
Trial summary
Primary Objective: To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6) will provide a clinical disease control rate (DCR) of at least 20% at the end of the chemotherapy. Secondary Objective: To evaluate other measures of tumour's responses and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- OXALIPLATIN (SR96669), 5-FLUOROURACIL (5-FU) and LEUCOVORIN (LV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to May 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of colon or rectum
- Measurable metastatic disease, either inoperable, or residual after surgical procedure
- No prior chemotherapy for metastatic disease
- For colon cancer: prior adjuvant chemotherapy with oxaliplatin that ended at least 12 months prior to enrollment.
- For rectal cancer: at least 12 months since prior use of oxaliplatin in neoadjuvant or adjuvant chemotherapy
- Adequate liver and kidney function:
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- Total bilirubin inferior to 1.5 ULN
- Serum Creatinine inferior to 150 umol/L
- Creatinine clearance (ClCr) > 30 mL/min
- ALT / AST inferior to 3 ULN
- Adequate hematological function
- Neutrophils > or equal 1.5 x 109/L
- Platelets > or equal 100 x 109/L
Who cannot join
- Metastatic disease presenting without prior adjuvant chemotherapy
- Metastatic disease presenting after non-oxaliplatin-containing adjuvant chemotherapy
- Peripheral sensory or motor neuropathy > grade 1
- Eastern Cooperative Oncology Group (ECOG) Performance status > 2
- Other active malignancy
- History of known allergy to oxaliplatin or other platinum compounds, to 5-FU, to Leucovorin or to any ingredients in the formulations or the containers
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- Patients who are pregnant, or breast-feeding
- Patients with severe renal impairment (ClCr < 30 mL/min)
- Pernicious anemia or other megaloblastic anemia with Vitamin B12 deficiency
- Patients with reproductive potential not implementing accepted and effective method of contraception (the definition of effective method of contraception will be based on the investigators' judgment)
- Participation in another clinical trial with any investigational drug within 30 days prior to study screening
- For patient who will receive Bevacizumab: Bevacizumab is contraindicated in patients with know hypersensitivity to any components of the product and to Chinese hamster ovary cell product or other recombinant human or humanized antibodies
- Presence of any symptoms suggesting brain metastasis
- 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: A Phase II Study of Modified FOLFOX-6 Chemotherapy as First-line Treatment of Metastatic Colorectal Cancer in Patients Who Have Received Oxaliplatin-based Adjuvant Chemotherapy
Primary Objective:
- To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6) will provide a clinical disease control rate (DCR) of at least 20% at the end of the chemotherapy.
Secondary Objective:
- To evaluate other measures of tumour's responses and safety.
- Conditions
- Colorectal Neoplasms
- Being tested
- OXALIPLATIN (SR96669), 5-FLUOROURACIL (5-FU), LEUCOVORIN (LV), BEVACIZUMAB
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OXALIPLATIN (SR96669)Drug
Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV
5-FLUOROURACIL (5-FU)Drug
Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV
LEUCOVORIN (LV)Drug
Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV
BEVACIZUMABDrug
Pharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients will receive modified FOLFOX-6 regimen:
* oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion)
* LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin)
* 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2)
A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician. Receives: Drug: OXALIPLATIN (SR96669); Drug: 5-FLUOROURACIL (5-FU); Drug: LEUCOVORIN (LV); Drug: BEVACIZUMAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint for the first thirteen patients according to the Simons Design: Clinical DCR (Disease Control Rate) at the end of stage I, based on Response Evaluation Criteria on Solid Tumors (RECIST) criteria.
Measured: At the end of 8 cycles or end of treatment which occurs first.
Secondary outcomes (4)
Progression-free survival (PFS)
Measured: evaluated at 10 weeks, 16 weeks and 40 weeks
Duration of response
Measured: evaluated at 10 weeks, 16 weeks and 40 weeks
Adverse events
Measured: At each visit, i.e. every two weeks
Overall response rate of stage I and II
Measured: evaluated at week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Affairs, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988897
- Sponsor's protocol ID
- OXALI_L_03943
- Status last verified
- Dec 2009
- First submitted
- 28 Sep 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Modified FOLFOX-6 Chemotherapy as First-line Treatment of Metastatic Colorectal Cancer in Patients Who Have Received Oxaliplatin-based Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT00988897
- Acronym / sponsor ID
- OXALI_L_03943
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 2 Oct 2009 (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 Objective:
- To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6) will provide a clinical disease control rate (DCR) of at least 20% at the end of the chemotherapy.
Secondary Objective:
- To evaluate other measures of tumour's responses and safety.
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 (SR96669), Drug: 5-FLUOROURACIL (5-FU), Drug: LEUCOVORIN (LV), Drug: BEVACIZUMABPatients will receive modified FOLFOX-6 regimen: * oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion) * LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin) * 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2) A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically proven adenocarcinoma of colon or rectum
- Measurable metastatic disease, either inoperable, or residual after surgical procedure
- No prior chemotherapy for metastatic disease
- For colon cancer: prior adjuvant chemotherapy with oxaliplatin that ended at least 12 months prior to enrollment.
- For rectal cancer: at least 12 months since prior use of oxaliplatin in neoadjuvant or adjuvant chemotherapy
Key exclusion criteria (14 listed)
- Metastatic disease presenting without prior adjuvant chemotherapy
- Metastatic disease presenting after non-oxaliplatin-containing adjuvant chemotherapy
- Peripheral sensory or motor neuropathy > grade 1
- Eastern Cooperative Oncology Group (ECOG) Performance status > 2
- Other active malignancy
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 |
|---|---|---|
| OXALIPLATIN (SR96669)Pharmaceutical form: Lyophilized powder for injection (50mg/vial or 100mg/vial) or aqueous solution (50mg/10mL or 100mg/20mL) Route of administration: IV | Drug | 1 |
| 5-FLUOROURACIL (5-FU)Pharmaceutical form: vials of 5g/100mL (50mg/mL) Route of administration: IV | Drug | 1 |
| LEUCOVORIN (LV)Pharmaceutical form: vials of 50mg/5mL or 500mg/50mL (10mg/mL) Route of administration: IV | Drug | 1 |
| BEVACIZUMABPharmaceutical form: vials of 100mg/4mL or 400mg/16mL (25mg/mL) Route of administration: IV | Drug | 1 |
Primary outcome
Primary endpoint for the first thirteen patients according to the Simons Design: Clinical DCR (Disease Control Rate) at the end of stage I, based on Response Evaluation Criteria on Solid Tumors (RECIST) criteria.
Time frame: At the end of 8 cycles or end of treatment which occurs first.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: evaluated at 10 weeks, 16 weeks and 40 weeks
Duration of response
Time frame: evaluated at 10 weeks, 16 weeks and 40 weeks
Adverse events
Time frame: At each visit, i.e. every two weeks
Overall response rate of stage I and II
Time frame: evaluated at week 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 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.
Medical Affairs 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 (SR96669), 5-FLUOROURACIL (5-FU) and LEUCOVORIN (LV) in people with Colorectal Neoplasms, run by Sanofi at 1 site in Canada.
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 13 inclusion and 14 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: withdrawn, as of the sponsor's last update on 23 Dec 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 Canada. 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 withdrawn before enrolling participants, so there are no results.
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?
Primary endpoint for the first thirteen patients according to the Simons Design: Clinical DCR (Disease Control Rate) at the end of stage I, based on Response Evaluation Criteria on Solid Tumors (RECIST) criteria. (time frame: At the end of 8 cycles or end of treatment which occurs first.). 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 23 Dec 2009.