A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT01130519|
Recruitment Status : Recruiting
First Posted : May 26, 2010
Last Update Posted : January 13, 2020
- At the present time, there are no drugs that have been proven to work in patients with papillary kidney cancer that has spread (metastasized) beyond the kidneys. Researchers are interested in determining whether the combination of the drugs bevacizumab and erlotinib can be used to treat metastatic papillary kidney cancer.
- Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC) is an inherited type of papillary kidney cancer (it runs in families). Papillary kidney cancer can also occur sporadically, or without a family connection. More research is needed to determine whether treatments for papillary kidney cancer, such as bevacizumab and erlotinib, work in inherited or sporadic types of kidney cancer, and if so, whether there are any differences.
-To determine the effectiveness of the combination of bevacizumab and erlotinib as a treatment for patients with (1) metastatic HLRCC kidney cancer and (2) metastatic kidney cancer not associated with HLRCC (or sporadic papillary RCC).
- Individuals 18 years of age or older who have been diagnosed with papillary kidney cancer that has spread beyond the kidneys.
- Participants may have either HLRCC or sporadic papillary kidney cancer.
- Participants will be screened with a full medical history, physical examination, blood and urine tests, and CT and other scans to evaluate tumor size and treatment options.
- Participants will receive 28-day treatment cycles of bevacizumab (given intravenously every 2 weeks) and erlotinib (a tablet taken by mouth daily).
- Every cycle, participants will return for regular blood and urine tests. Every other cycle, participants will have imaging scans to assess tumor size and response to treatment. Female participants who have uterine fibroid tumors related to their kidney cancer may have additional scans to assess tumor size and response to treatment.
- Participants will continue to receive treatment on the study until their tumors grow or spread to new areas (disease progression), intolerable side effects develop, a better treatment option becomes available, the study closes, it is unsafe to continue treatment, or the participant decides not to remain in the study.
|Condition or disease||Intervention/treatment||Phase|
|HLRCC Sporadic Papillary Renal Cell Cancer||Drug: Bevacizumab Drug: Erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer|
|Actual Study Start Date :||May 6, 2010|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
All patient will be receiving fixed starting dose of bevacizumab (10 mg /kg IV every 2 weeks) and erlotinib (150 mg/day PO)
Commercially available. Administered by intravenous infusion.
Commercially available. Administered orally
- Overall response rate [ Time Frame: 4-5 years ]Proportion of patients whose tumors shrunk after therapy
- Progression-free survival, duration of response, and overall survival. [ Time Frame: 4-5 years ]Median amount of time subject survives without disease progression after treatment
- Effect on potential biomarkers of angiogenesis in plasma such as VEGF and soluble VEGFR2. [ Time Frame: 4-5 years ]Correlation between treatment and potential biomarkers such as VEGF and soluble VEGFR2
- Determine the extent of TGF upregulation and/or EGFR expression/ pathway activation in leiomyomas/ RCC tumor tissue. [ Time Frame: 4-5 years ]EGFR expression/ pathway activation in leiomyomas/ RCC tumor tissue
- Prevalence of somatic FH mutations/inactivation in patients with sporadic papillary RCC. [ Time Frame: 4-5 years ]Correlation between treatment and prevalence of somatic FH mutations
- Effect on circulating endothelial cells and endothelial progenitor cells. [ Time Frame: 4-5 years ]Correlation between circulating endothelial cells and endothelial progenitor cells after treatment
- Evaluate modulation of HIF, VEGF and EGFR pathways in cutaneous leiomyomas (in patients with HLRCC) and in renal tumors following therapy. [ Time Frame: 4-5 years ]Modulation of HIF, VEGF and EGFR pathways in cutaneous leiomyomas and in renal tumors after therapy
- Effect on HLRCC associated uterine and skin leiomyomas. [ Time Frame: 4-5 years ]Correlation between therapy and skin leiomyomas
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130519
|Contact: Megan vaughan, R.N.||(301) email@example.com|
|Contact: Ramaprasad Srinivasan, M.D.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Ramaprasad Srinivasan, M.D.||National Cancer Institute (NCI)|