Metastatic or progressive sarcomatoid carcinoma of the lung (carcinoma with pleomorphic, sarcomatoid, or sarcomatous elements)
Conditions
Interventions
Carboplatin+Paclitaxel+Bevacizumab or Carboplatin+Paclitaxel if unfit for Bevacizumab treatment.
Sponsors
Hokkaido Lung Cancer Clinical Study Group North East Japan Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 20-74 years 2) Histologically confirmed diagnosis of sarcomatoid carcinoma of the lung. (carcinoma with pleomorphic, sarcomatoid, or sarcomatous elements). Cytological diagnosis is not possible. 3) Stage IIIB/IV or postoperative recurrence. 4) No prior chemotherapy or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last administration of adjuvant chemotherapy. 5) Patients who have measurable lesions. 6) Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1. 7) Adequate function of main organ. White blood cell count>=3000/mm3 Absolute granulocyte count >= 1500/mm3 Hemoglobin >= 9.0g/dL Platelet count >= 100,000/mm3 Serum bilirubin <= 1.5 mg/dL AST and ALT <100 IU/l Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min PaO2 (Room air) >=60Torr (or SpO2>=95%) Proteinuria<1+ 8) Life expectancy more than 3 months. 9) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Previous histories of drug allergy. 2) Serious concomitant infection. 3) Usages of oral steroids or immunosuppressive agents. 4) Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, or uncontrolled diabetes. 5) Interstitial pneumonia or pulmonary fibrosis on chest CT scans. 6) Severe pleural, abdominal, or cardiac effusion. 7) Major surgical procedures within 3 weeks or prior systemic therapy including radiotherapy within 2 weeks prior to study entry . 8) Patient in acknowledgment of hemoptysis (2.5 ml or more) or clinically important bleeding or a clot-related event. 9) Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 90 mmHg). 10) Brain metastasis with uncontrollable symptoms. 11) Tumor permeation to chest great vessels. 12) Cavity in tumor. 13) Receiving anticoagulant drug (except aspirin under 325mg/day). 14) Patients with active concomitant malignancy. 15) Pregnant or lactating women. 16) Inappropriate patients judged by physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall survival Safety | — |
Countries
Japan
Contacts
Public ContactSatoshi Oizumi
Hokkaido Cancer Center Department of Respiratory Medicine
Outcome results
None listed