Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
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| ClinicalTrials.gov Identifier: NCT00305188 |
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Recruitment Status :
Completed
First Posted : March 21, 2006
Last Update Posted : May 4, 2016
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Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group.
Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen.
Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastases Colorectal Neoplasms Colorectal Carcinoma | Drug: Xaliproden (SR57746A) Drug: Placebo Drug: Oxaliplatin Drug: 5-Fluorouracil Drug: Leucovorin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 879 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | A Multicenter, Randomized Double-blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV |
| Study Start Date : | December 2005 |
| Actual Primary Completion Date : | October 2009 |
| Actual Study Completion Date : | October 2009 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Xaliproden (SR57746A) |
Drug: Xaliproden (SR57746A)
oral administration Drug: Oxaliplatin IV administration Drug: 5-Fluorouracil IV administration
Other Name: 5-FU Drug: Leucovorin IV administration
Other Name: LV |
| Placebo Comparator: Placebo |
Drug: Placebo
oral administration Drug: Oxaliplatin IV administration Drug: 5-Fluorouracil IV administration
Other Name: 5-FU Drug: Leucovorin IV administration
Other Name: LV |
- Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment [ Time Frame: Q2W during treatment, Q4W to Q12W during post-treatment follow-up ]
- Main: response rate using RECIST criteria [ Time Frame: Q8W ]
- Other: nerve conduction studies [ Time Frame: baseline, end of treatment with oxaliplatin, end of treatment with study drug ]
- Other: progression free survival and survival [ Time Frame: Q8W and study period ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Main inclusion criteria :
- Histologically or cytologically-proven metastatic cancer of the colon or rectum.
- Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease).
- Male or female aged >18 years.
- WHO Performance Status (PS) : 0 or 1.
- Measurable disease.
- No prior chemotherapeutic regimen for metastatic disease.
- Disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy).
- Prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization.
- Signed written informed consent prior to study entry.
Exclusion Criteria:
Main exclusion criteria :
- Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information.
- Received chemotherapeutic agents other than 5-FU, LV, Levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy.
- Peripheral neuropathy >Grade 1.
- Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy.
- Concurrent active cancer originating from a primary site other than colon or rectum.
- Presence of any symptom suggesting brain metastasis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305188
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Argentina | |
| Sanofi-Aventis Administrative Office | |
| Buenos Aires, Argentina | |
| Australia | |
| Sanofi-Aventis Administrative Office | |
| Macquarie Park, Australia | |
| Brazil | |
| Sanofi-Aventis Administrative Office | |
| Sao Paulo, Brazil | |
| Canada | |
| Sanofi-Aventis Administrative Office | |
| Laval, Canada | |
| Chile | |
| Sanofi-Aventis Administrative Office | |
| Santiago, Chile | |
| Germany | |
| Sanofi-Aventis Administrative Office | |
| Berlin, Germany | |
| Hungary | |
| Sanofi-Aventis Administrative Office | |
| Budapest, Hungary | |
| Italy | |
| Sanofi-Aventis Administrative Office | |
| Milano, Italy | |
| Poland | |
| Sanofi-Aventis Administrative Office | |
| Warszawa, Poland | |
| Portugal | |
| Sanofi-Aventis Administrative Office | |
| Porto Salvo, Portugal | |
| Spain | |
| Sanofi-Aventis Administrative Office | |
| Barcelona, Spain | |
| United Kingdom | |
| Sanofi-Aventis Administrative Office | |
| Guildford Surrey, United Kingdom | |
| Study Director: | Clinical Sciences & Operations | Sanofi |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00305188 |
| Other Study ID Numbers: |
EFC5505 EUDRACT : 2005-002570-30 |
| First Posted: | March 21, 2006 Key Record Dates |
| Last Update Posted: | May 4, 2016 |
| Last Verified: | April 2016 |
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Neurotoxicity syndromes Paresthesia Oxaliplatin Xaliproden |
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Colorectal Neoplasms Neurotoxicity Syndromes Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Nervous System Diseases Poisoning Chemically-Induced Disorders |
Oxaliplatin Fluorouracil Xaliproden Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents |