This trial is evaluating whether Lenvatinib will improve 1 primary outcome and 5 secondary outcomes in patients with Metastatic Clear Cell Renal Cell Carcinoma. Measurement will happen over the course of Start of study drug to death due to any cause, assessed up to 2 years.
This trial requires 90 total participants across 2 different treatment groups
This trial involves 2 different treatments. Lenvatinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
"The most common cause of carcinoma in Africa is infection with Helicobacter pylori (H. pylori), but it is also present in those without H. pylori infection. A large number of patients have undetected gastric atrophy. Gastric carcinoma may not necessarily be related to H. pylori infection, and other factors such as diet, genetics, and lifestyle may play a role in the development of gastric carcinoma. There are no randomized controlled trials that have examined whether eradication of H. pylori decreases risk or improves survival from advanced gastric carcinoma, so it will be difficult to determine which patients might benefit from this intervention." - Anonymous Online Contributor
"The study did not show superiority of lenvatinib over a placebo for OS and PFS. However, the median time to progression was significantly longer in patients on lenvatinib compared to the placebo group." - Anonymous Online Contributor
"Lenvatinib exerts activity against human cancer cell lines derived from solid tumors including breast cancer, non-small cell lung cancer, and colorectal cancer. It may be a useful drug for patients with these cancers who currently have no treatment options. Further studies will determine if this drug has any benefit in people with other types of cancer." - Anonymous Online Contributor
"The overall proportion of patients receiving chemotherapy was only 7% (20% carboplatin + cyclophosphamide + epirubicin); this compares well with other studies of similar patient populations. The proportion of patients receiving chemotherapy was lowest for patients with stages I and II disease (1%). Patients who were treated with curative intent had higher overall proportions of chemotherapy than those who received palliative care." - Anonymous Online Contributor
"The likelihood of developing carcinoma increases with age. It is not uncommon to have all five risk factors present at the same time. People with a high body mass index are more likely than others to develop carcinoma, especially if their weight is increased after menopause. Cigarette smoking seems to increase the risk of developing carcinoma in both genders. The risk also increases with increasing number of cigarettes smoked. Of course, the risk decreases with quitting smoking. High blood sugar levels increase the risk of developing carcinoma. Diabetes control ameliorates the risk of developing cancer. There is an association between obesity and developing carcinoma but the reason is unknown. The risk of developing cancer increases with decreasing kidney function." - Anonymous Online Contributor
"Patients who have had prior chemotherapy or curative surgery may be best suited for clinical trials, whereas patients with poor performance status, significant comorbidities, or less than two weeks' survival may present a subpopulation at risk for toxicity and failure to complete treatment." - Anonymous Online Contributor
"As surgical techniques improved, so did the survival rates of patients with squamous cell cancer; however, those with adenocarcinoma had worse outcomes. The cause of carcinoma remains unknown, but the following three hypotheses seem most plausible: 1) carcinoma develops from an existing benign lesion; 2) carcinoma develops from a pre-existing carcinoma; 3) carcinoma develops in response to a physical change (e.g., radiation or chemical exposure) in the surrounding tissue." - Anonymous Online Contributor
"Lenvatinib was effective in patients with advanced metastatic renal cell carcinoma (mRCC) who had received prior systemic therapy. The most common adverse events included fatigue, hypertension, nausea, vomiting, headache, diarrhea, constipation, abdominal pain, rash, hyperlipidemia, and peripheral edema. Serious adverse events were rare and included pulmonary embolism, syncope, bronchospasm, dyspnea, pleuritis, respiratory failure, pneumonitis, and thrombosis. There were no significant differences between patients who received lenvatinib monotherapy and those who received lenvatinib plus everolimus. The study was sponsored by AbbVie Inc." - Anonymous Online Contributor
"Lenvatinib is generally used in combination with other agents, including chemotherapy (including paclitaxel and docetaxel). The combination of lenvatinib with agents such as paclitaxel shows promise in preclinical models; however, single agent and combination studies conducted in the clinic have not shown benefit. The combination with docetaxel does not appear to improve outcomes in patients with relapsed aggressive B-cell lymphomas. These data suggest that further investigation of the combination of lenvatinib with chemotherapeutic agents, such as docetaxel, is warranted." - Anonymous Online Contributor
"In this exploratory analysis, lenvatinib was well tolerated and appeared to be effective as first line therapy in patients with metastatic renal cell carcinoma. Serious adverse events were infrequent; most common side effects included headache and fatigue. Findings from a recent study provides an opportunity to evaluate the safety profile of lenvatinib across different types of solid tumors." - Anonymous Online Contributor
"Carcinomas are not always fatal due to their ability to metastasize. For example, an individual diagnosed with a T1a carcinoma may have zero metastatic risk. The long term survival rate for these patients, however, is still very high (94%). A patient with a T3b carcinoma has a five year survival rate of 20%. In both cases, metastatic risk was directly related to the stage of the carcinoma. The meta-analysis showed no significant difference in survival between different histologic types of carcinoma. Overall, the results indicate that even though carcinoma is not as deadly as other cancers, it is still important to treat these cancers as aggressively as possible." - Anonymous Online Contributor