Clinical trial NCT02393820: Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
Official title: Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Salivary Gland Carcinoma
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label, multicenter, single arm phase II study, set up in collaboration with the "Réseau d'Expertise Français sur les Cancers ORL Rares" (REFCOR), evaluating the activity and safety of single agent pazopanib in recurrent or metastatic tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).

Detailed description: In the non-ACC SGCHN population, assessment of the activity of pazopanib is exploratory without a predetermined study design, with up to 20 patients. A planned interim analysis of acute toxicities was conducted 3 months after the 14th non-ACC inclusion.

ACC As the endpoint will be evaluated at 6 months after treatment start, a one-stage phase II study design was chosen. The unacceptable 6-month rate of progression free survival is 20% and the promising 6-month rate of progression free survival is 40%.

43 patients are to be treated. If ≤12 patients alive without progression at 6 months will be observed, the drug will be declared ineffective.

If ≥13 patients alive without progression at 6 months will be observed, the drug will be declared promising.

The α error rate (accepting a poor treatment) is 0.07 and the β error rate (rejecting a promising treatment) is 0.07.

Analysis of results will be separated between non ACC and ACC.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of recurrent and/or metastatic salivary glands (including ACC and non ACC).
* Progressive disease within 6 months before inclusion as assessed by CT and/or MRI using at least two measurements (RECIST v1.0) with at least one measurable target lesion \>10 mm.
* Recurrent and/or metastatic salivary glands carcinoma failing locoregional therapy, without possibility of curative treatment.
* Patients may have had unlimited prior therapy but must have had at least 4 weeks between any chemotherapy, radiotherapy, surgery and study enrollment.
* Tumoral tissue must be provided for subsequent histological review and biomarker analysis.
* Euthyroid patient.
* Hepatic, renal, cardiac and hematology normal functions.
* Ability to take oral medication.

Exclusion Criteria:

* Non salivary gland carcinoma (lachrymal gland tumor is excluded).
* Known or symptomatic cerebral metastasis.
* Patients treated with strong inhibitor or inductor of CYP3A4 within 14 days before inclusion.
* Presence of uncontrolled infection.
* Diagnosis of any previous malignancy within the last 5 years, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.
* Stable disease.
* Corrected QT interval (QTc) \>480 msecs using Bazett's formula.

Primary outcomes:
measure: progression free survival
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest Paul Papin
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: Centre Val d'Aurelle Paul Lamarque
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Centre Hospitalier St Joseph
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint Cloud
country: France
facility: Institut Curie site St Cloud
city: Saint-herblain
country: France
facility: Institut Cancérologie de l'Ouest
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Centre Lacassagne Nice
name: Joel Mr Guigay, Pr
role: PRINCIPAL_INVESTIGATOR
References: