Clinical trial NCT00986440: Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
Official title: A Randomized, Double-Blind Placebo-Controlled Phase 2 Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 84
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: Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who achieved an objective response of Disease Control on first line therapy with Folinic acid (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed, metastatic CRC that have achieved confirmed maximal benefit of DC following treatment with standard first line chemotherapy of a 5-fluoropyrimidine plus either oxaliplatin or irinotecan. Patients should be entered onto this trial within 8 weeks of completing first line therapy;
* If CR was not achieved: measurable disease, i.e. at minimum one unidimensionally-measurable target lesion according to RECIST (Response Evaluation Criteria in Solid Tumors);
* Age \>= 18 years and Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2 at study entry;
* Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 3.0, grade =\< 1;
* Adequate organ and bone marrow function as evidenced by:

  * Haemoglobin \>= 10 g/dL (transfusion and/or growth factor support allowed);
  * Absolute neutrophil count (ANC) \>= 1.5 x 109/L;
  * Platelet count \>= 100 x 109/L;
  * Serum creatinine =\< 1.5 x ULN or creatinine clearance \>60 mL/min;
  * AST and alkaline phosphatase \<2.5 x ULN if without liver metastasis and =\< 5.0 x ULN if liver metastasis;
  * Total bilirubin =\< 2.0 x ULN;
  * Prothrombin time (PT)/International Normalised Ratio (INR) within normal limits (WNL) unless therapeutically anticoagulated;
* Women of childbearing potential and men must be willing to consent to using highly effective methods of contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter;
* Males with the potential to father children must use two of the following methods of contraception acceptable for the study (e.g. hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on trial treatment and for at least 3 months thereafter.
* All female subjects of childbearing potential must have a negative pregnancy test (plasma or urine) result within 7 days before initiating study treatment;
* Baseline laboratory tests and tumor assessments must have been performed within 2 weeks before initiating study treatment;
* Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC-approved ICF before performance of any study specific procedures or tests.

Exclusion Criteria:

* Anticipation of need for a major surgical procedure or RT during the study;
* Treatment with chemotherapy, hormonal therapy, minor surgery, or any investigational agent within 4 weeks before study enrolment. Treatment with immunotherapy, biological therapy, or major surgery within 6 weeks before study enrolment. Treatment with RT within 1 week before study enrolment.
* History of any of the following conditions: diabetes mellitus requiring treatment with insulin or oral agents;
* Concomitant use of other TZDs;
* Myocardial infarction with significant impairment of cardiac function (e.g., ejection fraction =\< 50%); severe/unstable angina pectoris; coronary/peripheral artery bypass graft; congestive heart failure; cerebrovascular accident (CVA) or transient ischemic attack (TIA), pulmonary embolism, or other clinically significant thromboembolic event; clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease \[COPD\] or asthma);
* Brain metastasis; an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis;
* Pleural or pericardial effusion. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor;
* Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy;
* Pregnant or breast feeding;
* Known history of severe hypersensitivity reactions to any of the components of CS 7017 formulations;
* Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment;

Primary outcomes:
measure: Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
timeFrame: 18 weeks postdose
Secondary outcomes:
measure: Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
timeFrame: At 12, 24, and 30 weeks postdose
measure: Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
timeFrame: At 3, 6, 9, and 12 months postdose
measure: Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
timeFrame: From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months
measure: Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
timeFrame: From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months
measure: Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
timeFrame: Baseline up to 30 days after last study dose, up to 3 years 3 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Fakulti nemocnice Brno
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Znojmo
country: Czechia
facility: Nemocnice Znojmo, p.o., Oddeleni radiacni a klinicke onkologie
city: Colmar
country: France
facility: Hopitaux civils de colmar
state: Cedex
city: Lyon
country: France
facility: Hopital Edouard Herriot
state: Cedex
city: Rennes
country: France
facility: Service d'Oncologie Medicale
state: Cedex
city: Saint Grégoire
country: France
facility: Centre Hospitalier Prive Saint Gregoire
city: Donauwörth
country: Germany
facility: Onkologische Praxis Donauwörth
city: Halle
country: Germany
facility: Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin
city: München
country: Germany
facility: Klinikum rechts der Isar
city: Candiolo
country: Italy
facility: Institute for Cancer Research and Treatment - IRCC
state: Torino
city: Genova
country: Italy
facility: Ospedale San Martino
city: Lecce
country: Italy
facility: Unita Operativa di Oncologia Medica
city: Siena
country: Italy
facility: Policlinico Santa Maria alle Scotte
city: Udine
country: Italy
facility: Azienda Ospedaliero Universitaria Santa Maria della Misericordia
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
city: Bytom
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
city: Gliwice
country: Poland
facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
city: Krakow
country: Poland
facility: VESALIUS Sp. z o.o.
city: Warszawa
country: Poland
facility: NZOZ ONKOLOG s.c.
city: Obninsk
country: Russian Federation
facility: Medical Radiological Research Centre
state: Kaluga
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
state: Tatarstan
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Centre n.a. Blokhin, RAMS
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital #1
city: Moscow
country: Russian Federation
facility: NUZ Semashko Central Clinical Hospital
city: St Petersburg
country: Russian Federation
facility: St-Petersburg State Institution of Public Health
city: St-Petersburg
country: Russian Federation
facility: Federal State Institution of Healthcare Clinical Hospital # 122 n.a.L.G Sokolov
city: Tula
country: Russian Federation
facility: Tula Regional Oncology dispensary
city: Barcelona
country: Spain
facility: H.Clinic I Provincial de Barcelona
state: Villaroel
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Terrassa (Barcelona)
country: Spain
facility: Hospital Mútua de Terrassa
city: Lutsk
country: Ukraine
facility: Volyn regional oncology dispensary
state: Volyn
city: Kiev
country: Ukraine
facility: Kyiv City Oncology Hospital
city: Sumy
country: Ukraine
facility: Sumy Regional Oncology Center
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
state: Middlesex
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: London
country: United Kingdom
facility: St.Bartholomew's Hospital
city: London
country: United Kingdom
facility: UCLH Cancer Clinical Trials Unit
city: Manchester
country: United Kingdom
facility: Christie Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: