Phase II trial of ramucirumab and docetaxel for previously treated NSCLC patients with malignant pleural effusio
- Conditions
- Advanced / recurrent non-small cell lung cancer (NSCLC)
- Registration Number
- JPRN-jRCTs071190013
- Lead Sponsor
- Shinnosuke Takeomto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
1) The patient has provided written consent after receiving sufficient explanation about the study prior to enrollment.
2) The patient is 20 years old or older on the day of enrollment.
3) The patient has histologically or cytologically confirmed NSCLC.
4) The patient's disease has a clinical staging of Stage IV.
4a) The patient with recurrent disease after adjuvant or neoadjuvant therapy or patients who have received combined chemotherapy and radiation for locally advanced disease are eligible, if:
- patient had progression disease within 6 months after completion of adjuvant or neoadjuvant platinum-based therapy (adjuvant therapy will be considered the patient's one and only prior firstline, platinum-based chemotherapy); or
- patient had progressive disease more than 6 months after completion of therapy AND has developed progressive disease on or after one subsequent chemotherapy regimen for advanced/metastatic disease.
5) The patient who have had disease progression during or after one and only one prior platinum-based chemotherapy regimen with or without maintenance therapy for advanced/metastatic disease or in combination with Immune check point inhibitor.
6) Maintenance chemotherapy is defined as therapy given within 42 days after the last dose of platinum-based chemotherapy in patients with ongoing clinical benefit (complete response, partial response, or stable disease) after platinum-based first-line induction chemotherapy.
7) The patient has clinically malignant pleural effusion and has not undergone pleurodesis after discontinuation of prior treatment.
8) The patient has asymptomatic brain metastasis or spinal metastasis that requires radiological or surgical intervention.
9) The patient does not have symptomatic superior vena cava syndrome.
10) The patient has no invasion or narrowing of major blood vessels due to cancer by radiologically documented evidence.
11) The patient has no cavity in tumor by radiologically documented evidence.
12) At least seven days have passed since the completion of radiation therapy for metastatic lesions to relieve symptoms. At least 28 days must have passed if the field of radiation therapy for symptom relief extended to the chest.
13) The patient has an ECOG PS of 0 or 1 at the time of enrollment.
14) The patient does not have
- cirrhosis at a level of Child-Pugh B (or worse) or
- cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
15) The patient has adequate organ function, defined as:
White blood cells: >=3000/uL
Neutrophils: >=1500/uL
Hemoglobin: >=9.0g/dL
Platelets: >=10.0x104/uL
Total bilirubin: =<1.5 times the upper limit normal (ULN)
Aspartate aminotransferase (AST): =<3.0 times the ULN or 5.0 times the ULN in the setting of liver metastasis
Alanine aminotransferase (ALT): =<3.0 times the ULN or 5.0 times the ULN in the setting of liver metastasis
Creatinine: =<1.5 times the ULN, or creatinine clearance of 40 mL/min or more
International normalized ratio (INR): =<1.5 (=< 3.0 if patient is taking warfarin)
Prothrombin time and partial thromboplastin time: 1.5 x upper limit of normal (ULN)
Proteinuria: Less than 1+
16) The patient has agreed to practice medically approved methods of contraception (condom, pessary, etc.) if he/she has reproductive capacity.
1) The patient requires treatments for pleural effusion such as urgent (within 24 hours) and continuous pleuraleffusion drainage for displacement of the mediastinum due to accumulation of pleural effusion.
2) The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment. Furthermore, any patient with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months will be excluded.
3) The patient has a planned major surgery during the course of the trial.
4) The patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy.
*The last dose of any chemotherapies including bevacizumab must be at least 28 days from the time of enrollment.
5) The patient has untreated CNS metastases. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 14 days prior to enrollment, or after surgical resection performed at least 28 days prior to enrollment. The patient may have no evidence of Grade >=1 CNS hemorrhage based on pretreatment MRI or IV contrast CT scan (performed within 21 days before enrollment).
6) The patient has radiologically documented evidence of major blood vessel invation or encasement by cancer
7) The patient has radiologic evidence of intratumor cavitation, regardless of tumor histology
8) The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to first dose of protocol therapy.
9) The patient is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents. Patients receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters defined in the inclusion criteria (INR=<1.5 or PT=<1.5 x ULN) are met.
10) The patient is receiving chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or receiving other antiplatelet agents (for example, clopidogrel, ticlopidine and dipyridamole). Aspirin use at doses up to 325 mg/day is permitted.
11) Patients with a history of hemoptysis within 2 months prior to enrollment.
12) The patient has clinically relevant congestive heart failure (NYHA II-IV) or cardiac arrhythmia poorly controlled by medications.
13) The patient has uncontrolled arterial hypertension >=150 / >=90 mm Hg despite standard medical management.
14) The patient has had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment.
15) The patient has significant bleeding disorders, vasculitis, or experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment.
16) History of GI perforation and / or fistulae within 6 months prior to enrollment.
17) The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
18)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pleural effusion control rate 8 weeks after the start of treatment
- Secondary Outcome Measures
Name Time Method Objective response rate, Progression-free survival, One-year survival rate, Overall survival, Toxicity profile