ACTRN12609000643279
Completed
Phase 2
A phase 2 trial evaluating the effect of Everolimus alternating with Sunitinib on progression-free survival in patients with advanced renal cell carcinoma.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The University of Sydney
- Enrollment
- 55
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients will be eligible for enrollment if they fulfill all of the following criteria:
- •1\. Renal cell carcinoma with a clear cell component confirmed by histology or cytology
- •2\. Advanced disease: metastatic OR locally advanced OR locally recurrent; AND, not suitable for resection
- •3\. Male or female, aged 18 years or older
- •4\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •5\. Low or intermediate Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk score (8, 9\), i.e. no more than 2 of the following: Karnofsky performance status 1\.5 times institutional upper limit of normal; Anaemia (haemoglobin less than institutional lower limit of normal); Hypercalcemia (corrected serum calcium \>2\.5 mmol/L); Interval since diagnosis less than 1 year.
- •6\. Target and/or non\-target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1\.1 (15\). Patients participating in Positron Emission Tomography (PET) studies must have a lesion assessable by PET (at least 2cm in diameter in an organ not subject to undue PET artefact, as determined by the site Principal Investigator in conjunction with nuclear medicine physicians).
- •7\. Expected survival of at least 3 months.
- •8\. Within 3 weeks prior to registration, vital laboratory parameters should be within the normal range, except for the following parameters, which should be within the ranges specified: Neutrophils \>/\= 1\.5 x 109/L; Platelets \>/\= 90 x 109/L; International Normalised Ratio (INR) 9\. Left ventricular ejection fraction \>/\= 55% on gated cardiac blood pool scan, or normal left ventricular function and fractional shortening on echocardiogram (according to institutional limits).
- •10\. Systolic blood pressure 11\. Able to commence treatment within 7 days of registration.
Exclusion Criteria
- •Patients will be excluded from the study for any of the following reasons:
- •1\. Prior treatment with Vascular Endothelial Growth Factor (VEGF)\-targeting agents (e.g. bevacizumab) or multi\-kinase inhibitors (e.g. sorafenib or sunitinib), or mammalian Target of Rapamycin (mTOR)\-targeting agents (e.g. everolimus or temsirolimus).
- •2\. Active central nervous system metastases. Patients may be eligible if they have central nervous system metastases that have been adequately treated (surgery or radiotherapy), do not require ongoing corticosteroids for control of symptoms, and have had no evidence of progression for at least three months.
- •3\. Other malignancy diagnosed within the last 5 years, except the following if adequately treated: superficial Squamous Cell Carcinoma (SCC) or Basal Cell Carcinoma (BCC) of skin, superficial bladder cancer (T1 and G1 or T1 and G2\), stage 1 cervical cancer.
- •4\. Treatment with an investigational agent in the last 4 weeks.
- •5\. Known to be Human Immunodeficiency Virus (HIV) positive (testing not mandatory unless clinically indicated).
- •6\. Evidence of chronic hepatitis due to Hepatitis B Virus (HBV) (HBV surface antigen positive) or Hepatitis C Virus (HCV) (HCV ribonucleic acid (RNA) positive). All potential participants will be tested for HBV surface antigen, HBV core antibody, HCV antibody, and HCV RNA if the HCV Ab is positive.
- •7\. Clinically significant heart disease (New York Heart Association (NYHA) Class III or IV).
- •8\. History of hypertension requiring hospitalisation.
- •9\. Other serious illnesses, e.g. active infection requiring antibiotics, bleeding disorders.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
evaluation of the activity of Everolimus as maintenance therapy for metastatic neuroendocrine carcinoma with pulmonary or gastroenteropancreatic origin.The aim of this study is to evaluate the activity of a maintenance therapy with everolimus 10 mg daily in patients with stable disease, partial response or complete response after 6 cycles of induction chemotherapy with cisplatin or carboplatin plus etoposide administered according to clinical practice.Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2014-003951-72-ITGruppo Oncologico Italiano Ricerca Cancro (GOIRC)
Completed
Phase 2
A multicenter phase II trial of everolimus for unresectable pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-based regimenresectable pancreatic neuroendocrine carcinomaJPRN-UMIN000012752ational Cancer Center Hospital East25
Active, not recruiting
Phase 1
A trial to investigate the use of Veregen ointment in the treatment of vulval intraepithelial neoplasia, a severe skin disorder that may lead to vulval cancer.Vulval intraepithelial neoplasia (VIN)MedDRA version: 16.1Level: LLTClassification code 10057313Term: Vulval intraepithelial neoplasia grade IIISystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2013-003107-19-GBniversity of Birmingham26
Active, not recruiting
Phase 1
Phase II trial evaluating the efficacy of durvalumab (MEDI4736) as second-line therapy in Non- Small-Cell Lung Cancer patients receiving concomitant steroidson- Small-Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10025122Term: Lung squamous cell carcinoma stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2018-003645-41-ITFONDAZIONE RICERCA TRASLAZIONALE84
Recruiting
Phase 2
Randomized, placebo-controlled phase II study of efficacy of morphine for dyspnea in patients with interstitial lung disease: JORTC-PAL15JPRN-jRCTs051190030Matsuda Yoshinobu50