Know Cancer

forgot password

Phase II Study of Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer

Phase 2
18 Years
59 Years
Open (Enrolling)
Non Small Cell Lung Cancer

Thank you

Trial Information

Phase II Study of Salvage Therapy With Sunitinib,Docetaxel and Platinum on Metastatic or Unresectable Non Small Cell Lung Cancer

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.

Inclusion Criteria:

1. Male or female,18 years of age or older.

2. Chemotherapy-naive patients with metastatic or unresectable non-small cell lung

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

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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate by RECIST criteria

Outcome Time Frame:

every 3 months

Safety Issue:


Principal Investigator

Cheng-Jeng Tai, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Section of Hematology-Oncology, Department of Medicine, Taipei Medical University Hospital


Taiwan: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

December 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • non small cell lung cancer
  • sunitinib
  • docetaxel
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms