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Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
Phase 3 trial testing Vinflunine in Recurrent or Metastatic Head and Neck Carcinoma in 459 participants. Completed in 23 November 2018.
| Lead sponsor | Pierre Fabre Medicament |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 459 |
| Start date | 25 April 2014 |
| Primary completion | 20 October 2017 |
| Estimated completion | 23 November 2018 |
| Sites | 1 location across France |
Pierre Fabre Medicament — full company profile →
Adults 18 to 80, any sex, with Recurrent or Metastatic Head and Neck Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time from randomization to the date of death or last follow-up. The survival duration of patients still alive, was censored at the date of last contact or last follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Vinflunine Plus Methotrexate | 7.1 | 5.7 – 8.4 |
| Methotrexate | 6.8 | 6.1 – 8.0 |
Time measured from the date of randomisation until date of progression or death from any cause (whichever came first)
| Group | Value | 95% CI |
|---|---|---|
| Vinflunine Plus Methotrexate | 2.8 | 2.6 – 3.3 |
| Methotrexate | 2.8 | 2.1 – 3.1 |
The objective response is defined as the best response designation recorded across all time points from the date of randomisation until disease progression.
| Group | Value | 95% CI |
|---|---|---|
| Vinflunine Plus Methotrexate | 17.8 | 13.1 – 23.4 |
| Methotrexate | 14.8 | 10.5 – 20.1 |
Percentage of best overall responses CR, PR and SD in the analysed population
| Group | Value | 95% CI |
|---|---|---|
| Vinflunine Plus Methotrexate | 50.9 | 44.2 – 57.5 |
| Methotrexate | 46.3 | 39.7 – 53.0 |
Duration of objective response will be measured for responders (CR+PR) from the time for CR or PR until the 1st date of documentation of recurrent or progressive disease or the date of death any cause.
| Group | Value | 95% CI |
|---|---|---|
| Vinflunine Plus Methotrexate | 4.2 | 2.5 – 5.6 |
| Methotrexate | 4.2 | 2.7 – 5.1 |
Time frame: 4 years 6 months 29 days. 5 subjects in the Vinflunine + Methotrexate arm and 2 patients in the Methotrexate arm did not receive any treatment. These patients were thus excluded from the safety population.The safety population consisted of all patients randomized and treated.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Vinflunine Plus Methotrexate | Methotrexate |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Tumour Haemorrage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Death | General disorders | — | — |
| General Physical Health Deterioration | General disorders | — | — |
| Tumour Necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Aspiration | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Reaction | System | Vinflunine Plus Methotrexate | Methotrexate |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Weight decreased | Investigations | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Pyrexia | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Pain | General disorders | — | — |
| Dyspnoea | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Creatinine renal clearance decreased | Investigations | — | — |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Weight increased | Investigations | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Neutropenia, Malignant neoplasm progression, Tumour Haemorrage, Febrile neutropenia, Anaemia, Leukopenia, Sepsis, Thrombocytopenia.
Data from ClinicalTrials.gov NCT02347332 adverse events section.
For patients relapsing after platinum-based therapy, few data are available. The current use of cetuximab associated with radiotherapy in localized disease and associated with platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine demonstrated superior antitumour activity to vinorelbine in preclinical animal models. Recent preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN, based on a clinical review, show encouraging antitumour activity and an acceptable safety profile. Therefore the combination of vinflunine and methotrexate appears a promising salvage regimen after platinum failure. The present study has been designed as a multicenter, randomised phase III study which will compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN patients having failed platinum-based therapy.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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