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Trial Title:
Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer
NCT ID:
NCT01019798
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Sunitinib
Conditions: Keywords:
non small cell lung cancer
sunitinib
docetaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
sunitinib, docetaxel, cisplatin
Description:
1. Sunitinib given 10 days within 14 days of each cycle。
2. Sunitinib 25 mg/day with adjust dosage according to patient's condition, but should
return to 25 mg when feasible or should withdraw from this study.
3. Docetaxel 40-50 mg/m2, cisplatin 50 mg/m2 every 2 weeks.
4. Overall 12 cycles (24 weeks)
Arm group label:
open label
Other name:
docetaxel(tyxant)
Summary:
Sunitinib shows anti-tumor activity in a variety of human non-small cell lung tumor ex
vivo models. Many Phases II and III clinical trials of sunitinib in several solid tumors
are completed or still ongoing. So far, the efficacy of sunitinb has been confirmed by
the phase III trial for imatinib-resistance or intolerance advanced gastrointestinal
stromal tumor patients. And sutent was approved to effective by two phase II trials in
advanced renal cell carcinoma patients after failure of immunotherapies, and one phase
III trial in treatment-naive advanced renal carcinoma patients. Sunitinib (SUTENT ®) has
been approved by U.S. Food and Drug Administration (FDA) for the treatment of advanced
renal carcinoma patients and in gastrointestinal stromal tumor patients who are
intolerant or progressed after imatinib mesylate. European Medicines Agency (EMEA)
conditionally granted the marketing approval for the treatment of metastatic renal
carcinoma patients after failure of immunotherapy.
A phase II trial (A6181040 study) on non-small cell lung cancer patients treated with
sunitinib alone showed anti-tumor activity. In 63 enrolled patients treated with 4/2
schedule (4 weeks treatment, then two weeks interruption), 7 patients are confirmed
partial response (overall response rate, 11%), and median progress-free time is 14.3
weeks. Presently, a phase III study is underway on non-small cell lung cancer patients
followed by and now is under recruiting.
Non-small cell lung cancer cells often over-express vascular endothelial growth factor
(VEGF) receptors. Besides, the expression of the VEGF ligands is also correlated with
increased tumor angiogenesis, as well as shortened survival time. One study treated with
VEGF-directed monoclonal antibody (bevacizumab) and VEGFR and platelet-derived growth
factor receptor (PDGFR) small molecule inhibitors (sunitinib) showed that some non-small
cell lung cancer patients are with anti-tumor activity.
The chemotherapy drugs, such as docetaxel and platinum-based compounds, were with
evidence that they have direct cytotoxicity to cancer cells. Therefore, the investigators
are paying attention to the efficacy of combining sunitinib and conventional chemotherapy
in this study.
The study is designed as first line of salvage therapy on metastatic or unresectable
non-small cell lung cancer patients. The main goals of this study is to evaluate the
overall response rate (ORR) and duration of response (DR) of sunitinib in combinational
with docetaxel and cisplatin in chemotherapy-naive advanced or metastatic non-small cell
lung cancer patients.
Detailed description:
Study Design This is a single-center, open-label, phase II clinical trial. Simon
two-stage analysis is adopted.The sample size in the first stage is 16 patients. The
length of study is approximately 24 months. The targeted subject is patient with
metastatic or unresectable non-small cell lung cancer.
Study Endpoints Primary Endpoint Assess the response rate of sunitinib, docetaxel and
cisplatin in the treatment of naïve chemotherapy metastatic or unresectable non-small
cell lung cancer patients.
Secondary Endpoint
1. Time to disease progression (defined as the time period from the start of
investigated medication to investigator assessed disease progression) at the end of
study.
2. Duration of survival (defined as the time period from the start of investigated
medication to death).
3. Safety profile of sunitinib in combination with docetaxel and cisplatin: cardiac
toxicity assessed in accordance with National Cancer Institute Common Toxicity
Criteria (version 3.0). The incidence of serious adverse events related to the
treatment and the incidence of specific adverse events (serious and non-serious)
such as gastro-intestinal perforation, wound healing complication, bleeding,
hypertension, arterial thromboembolic events and proteinuria will be investigated.
NCI-CTCAE criteria (version 3.0) will be used.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female,18 years of age or older.
2. Chemotherapy-naive patients with metastatic or unresectable non-small cell lung
cancer.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
4. Normal left ventricular ejection fraction (LVEF).
5. At least one unidimensionally measurable lesion with a diameter > 10 mm using CT
scan.
6. Life expectancy greater than 3 months.
7. Neutrophils 1,500/L, Platelets 100,000/L, AST/ALT 2.5 ULN (< 5 ULN if liver
metastases), Alkaline phosphatase 2.5 ULN, Serum bilirubin 1.5 ULN, Serum Creatinine
1.5 ULN.
8. Urine dipstick of proteinuria <2+. Patients discovered to have 2+ proteinuria on
dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must
demonstrate 1g of protein/24 hr.
9. Patients in this study should avoid having child. Women of childbearing potential
must have a negative serum pregnancy test done 1 week prior to the administration of
the study drug. She and her partner should prevent pregnancy (oral contraceptives,
intrauterine contraceptive device, barrier method of contraception in conjunction
with spermicidal jelly or surgically sterile) up to at least 6 months after last
treatment completion or the last drug dose, whatever happens first.
10. Signed written informed consent according to ICH/GCP and the local regulations
(approved by the Institutional Review Board [IRB]/Independent Ethics Committee
[IEC]) will be obtained prior to any study specific screening procedures.
11. Patient must be able to comply with the protocol.
Exclusion Criteria:
1. Poor condition and inappropriate situation to enter this study, which could be
determined by the principle investigator or in-charge attending physician.
2. Uncontrolled hypertension (systolic blood pressure > 160 mm Hg, diastolic blood
pressure > 90 mm Hg).
3. Prior exposure to VEGF inhibitors.
4. Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to Day 0 (Patients must have recovered from any major surgery), or
anticipation of need for major surgical procedure during the course of the study.
5. Planned radiotherapy for underlying disease (prior completed radiotherapy treatment
allowed).
6. Clinical or radiological evidence of CNS metastases.
7. Serious non-healing wound or ulcer.
8. Evidence of bleeding diathesis or coagulopathy.
9. Clinically significant (i.e. active) cardiovascular disease for example
cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable
angina, New York Heart Association (NYHA) grade II or greater congestive heart
failure, serious cardiac arrhythmia requiring medication. Stroke in the preceding
six months.
10. Current or recent (within 10 days prior to study treatment start) ongoing treatment
with anticoagulants for therapeutic purposes i.e. except for anticoagulation for
maintenance of potency of permanent indwelling IV catheters.
11. Evidence of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates use of an investigational drug or patient at high risk from
treatment complications.
12. Ongoing treatment with large dose aspirin (> 325 mg/day) or other medications known
to predispose to gastrointestinal ulceration (Continuous using NSAIDs).
13. Pregnancy (positive serum pregnancy test) and lactation.
14. Any other serious or uncontrolled illness which, in the opinion of the investigator,
makes it undesirable for the patient to enter the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
59 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Section of Hematology, Department of Medicine,Taipei Medical University Hospital
Address:
City:
Taipei
Zip:
110
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Cheng-Jeng Tai, M.D.
Phone:
886-2-27372181
Phone ext:
3903
Email:
cjtai@tmu.edu.tw
Investigator:
Last name:
Cheng-Jeng Tai, M.D.
Email:
Principal Investigator
Start date:
January 2009
Completion date:
December 2011
Lead sponsor:
Agency:
Taipei Medical University Hospital
Agency class:
Other
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
TTY Biopharm
Agency class:
Industry
Source:
Taipei Medical University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01019798