Clinical trial NCT01904253: A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy
Official title: An Open-Label, Randomized, Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin in Patients Requiring Second-Line Chemotherapy for Small Cell Lung Cancer That is Refractory or Sensitive to First-Line Platinum-Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Small Cell Lung Cancer (SCLC)
Keywords: Second line Small Cell Lung Cancer, (SCLC), Refractory or Sensitive to First line Platinum based chemotherapy
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Taiho Pharmaceutical Co., Ltd.
First posted: 2013-07-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on survival, how much time may pass without disease progression, and the safety of TAS-102.

Detailed description: This is a multicenter, open-label, two-arm, randomized Phase 2 study of TAS-102 versus Investigator's choice of therapy in patients requiring second-line chemotherapy for SCLC refractory or sensitive to first-line platinum-based chemotherapy. Investigator's choice of therapy is defined as second-line chemotherapy with IV topotecan (Europe/Japan) or IV amrubicin (Japan). Patients will be stratified by response to first-line platinum-based chemotherapy (sensitive vs refractory). Sensitive patients are defined as patients who did not progress within 90 days after the last dose, and refractory patients are defined as patients who never responded or who responded but had radiologic progression \< 90 days after the last dose.

Eligibility criteria: Inclusion Criteria:

1. Has provided written informed consent
2. Is ≥18 years of age for patients enrolled in Europe; or ≥20 years of age for patients enrolled in Japan
3. Has definitive histologically or cytologically confirmed SCLC (limited or extensive disease)
4. Has progressed or had recurrence within 30 days prior to randomization
5. Has at least one measurable lesion, as defined by RECIST criteria version 1.1
6. ECOG performance status of 0, 1, or 2
7. Is able to take medications orally
8. Has adequate organ function (bone marrow, kidney and liver)
9. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

1. Has cerebral metastases (unless metastases have been treated and controlled, metastases have been stable for at least 2-months post-intervention, and patient is not receiving corticosteroid treatment)
2. Certain serious illnesses or medical condition(s)
3. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
4. Has received TAS-102
5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
6. Is a pregnant or lactating female

Primary outcomes:
measure: Progression-free survival
timeFrame: Every 6 weeks from the start of study treatment (Day 1, Cycle 1). Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment.
Secondary outcomes:
measure: Overall survival
timeFrame: Survival status will be collected at 8-week intervals until death, for up to 12 months after the first dose of study medication for the last patient randomized or until the target number of events (deaths) is met, whichever is later.
measure: Safety monitoring including adverse events, vital signs, and laboratory assessments
timeFrame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH Universitaetsklinikum
state: Baden-Württemberg
city: Berlin
country: Germany
facility: Lungenklinik Heckeshorn- HELIOS Kliniken GmbH
city: Grosshansdorf
country: Germany
facility: LungenClinic Grosshansdorf
city: Koplin
country: Germany
facility: Klinikum Koeln-Merheim
city: Mainz
country: Germany
facility: St. Hildegardis-Krankenhaus- Katholisches Klinikum Mainz
city: Muenchen
country: Germany
facility: LMU-Campus Innenstadt
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria S. Luigi Gonzaga
state: Turin
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Aviano, Divisione Oncologia Medica A
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
city: Catania
country: Italy
facility: Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico
city: Cremona
country: Italy
facility: Azienda Ospedaliera Instituti Ospitalieri di Cremona
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo U.O Oncologia Medica
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
city: Sondalo
country: Italy
facility: A.O.V.V. Ospedale Eugenio Morelli-Sondalo
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Fukuoka
country: Japan
facility: National Kyushi Cancer Center
city: Hyogo
country: Japan
facility: Hyogo Cancer Center
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: Cancer Institute Hospital of Japanese Foundation for Cancer Research
Study officials:
affiliation: University of Turin San Luigi Hospital
name: Giorgio Scagliotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nippon Medical School Hospital Cancer Center
name: Kaoru Kubota, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scagliotti G, Nishio M, Satouchi M, Valmadre G, Niho S, Galetta D, Cortinovis D, Benedetti F, Yoshihara E, Makris L, Inoue A, Kubota K. A phase 2 randomized study of TAS-102 versus topotecan or amrubicin in patients requiring second-line chemotherapy for small cell lung cancer refractory or sensitive to frontline platinum-based chemotherapy. Lung Cancer. 2016 Oct;100:20-23. doi: 10.1016/j.lungcan.2016.06.023. Epub 2016 Jun 27.