Idiopathic pulmonary fibrosis
Conditions
Interventions
Carboplatin/paclitaxel combination therapy (dosage and administration) Paclitaxel (PAC):175-200mg/m2 at day1 and carboplatin (CBDCA): AUC 5-6min.mg/mL at day1 are administered and repeated every
Sponsors
Lung Oncology Group in Kyushu, Japan (LOGIK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient with idiopathic pulmonary fibrosis. 2) Patient with chemotherapy naïve confirmed by histological diagnosis or cytodiagnosis to be non-small cell cancer including the recurrent patient after surgery for primary lesion (except the patient treated with adjuvant chemotherapy including UFT) and excluding the patient after radiation exposure for primary lesion. When palliative radiation therapy (gamma knife, irradiation to a bone metastatic focus) to any place other than the primary lesion is provided, it can be registered if more than 2 weeks after the radiation therapy passes. 3) Patient with clinical stage of IIIB and IV period that radical cure irradiation is impossible. *The patient impossible of pleural effusion control is excluded. The patients with pleural effusion control can be enrolled after more than 4weeks of pleurodesis by MINO or OK432, and are confirmed that there is no exacerbation of idiopathic pulmonary fibrosis after the drug administration. *The patient not to hope for an operation eve if it is operable, the patient that cannot but give up radiation therapy because of pulmonary fibrosis eve if it is possible for radical cure irradiation, the enrollment of such patients are possible. 4) Age 20 years or older and younger than 75 years (at the date of informed consent). 5) ECOG performance status (PS) :0-1 6) Patients with sufficient organ function. 7) Patients with survival expectation of more than 12 weeks. 8) Patient with written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with suspicion of exacerbation of idiopathic pulmonary fibrosis (increase in such as LDH, KL-6, SP-A, SP-D, so on). 2) Patient with superior vena cava syndrome. 3) Patient with the history of severe drug allergy. 4) Patient with pleural effusion, ascites, and pericardial effusion need for treatment of such as drainage. 5) Patient with severe infection and other severe complications (gastrointestinal hemorrhage, heart disease, etc). 6) Patient with symptomatic brain metastasis. 7) Patients with steroid administration. 8) Patient with active double cancer. 9) Patient with diabetes hard to control. 10) Unstable psychic disorder. 11) Pregnant or breast-feeding females. 12) Inappropriate patients for this study judged by the physicians. In group B, to confirm hypersensitivity to polyoxyethylene castor oil (Cremophor EL) product (such as cyclosporine), curing caster oil product (such as injectable vitamin), and alcohol hypersensitivity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of acute exacerbation of idiopathic pulmonary fibrosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of acute exacerbation of idiopathic pulmonary fibrosis and death rate about the patient treated with anticancer drug. Grading and frequency of other adverse event (CTCAE ver.3.0 Japanese edition/JCOG/JSCO) and response rate. | — |
Countries
Japan
Contacts
Public ContactNoriyuki Ebi
Iizuka Hospital Department of Respiratory Medicine
Outcome results
None listed