A Phase 1 interventional study of Erlotinib Hydrochloride and Bortezomib in Advanced Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-07-13.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
The goal of this clinical research study is to find the highest tolerable dose of Tarceva (erlotinib hydrochloride) that can safely be given in combination with Velcade (bortezomib). The safety of this drug combination will also be studied.
The Study Drugs:
Erlotinib hydrochloride and bortezomib are both designed to block proteins that are thought to cause cancer cells to grow. These drugs may help slow the growth of tumors.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of erlotinib hydrochloride and bortezomib based on when you join the study. Up to 4 dose levels of this study drug combination will be tested. There will be 3-6 participants enrolled at each dose level of the study drug combination.
The first group of participants will receive the lowest dose level of erlotinib hydrochloride (Group 1). If all of Group 1 tolerate that dose level, the next group (Group 2) will receive a higher dose. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen (Groups 2-4). This will continue until the highest tolerable dose of the study drug combination is found. However, if Group 1 did not tolerate the first dose level, the next group will receive a lower dose (called Dose Level -1). If that dose level is still intolerable, the third group will receive an even lower dose (called Dose Level -2).
The dose of bortezomib will be based in which group you in. Groups 1 and 2 will receive the same dose, Group 3 will receive a higher dose, and Group 4 will receive an even higher dose.
After the highest tolerable dose is found, up to an additional 10 participants, called the "expansion group," will receive the study drug combination at that dose.
Study Drug Administration:
Erlotinib hydrochloride will be taken by mouth 1 time every day for 21-days, called a study "cycle." You should take erlotinib hydrochloride on an empty stomach either 1 hour before eating or 2 hours after eating.
Depending on which dose level you are assigned to, you will receive bortezomib by vein over about 1-5 minutes on Days 1 and 8, or on Days 1, 4, 8, and 11 of each 21-day cycle.
Study Visits:
You will have a single study visit just before each cycle. At these visits, the following tests and procedures will be performed:
After every 2 cycles (Cycles 2, 4, 6, and so on), you will have a CT or MRI scan to check the status of the disease.
Length of Study:
You may continue taking the study drugs for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur.
Follow-up Visit:
About 30 days after the last dose of study drugs, you will have a follow-up visit. You will be asked to return any unused study drug. At this visit, the following tests and procedures will be performed:
This is an investigational study. Bortezomib and erlotinib hydrochloride are both FDA approved and commercially available. Bortezomib is FDA approved for the treatment of multiple myeloma. Erlotinib hydrochloride is FDA approved for the treatment of lung cancer and pancreatic cancer. The use of these drugs together is investigational and authorized for use in research only.
Up to 48 participants will take part in this study. All will be enrolled at M. D. Anderson.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Up to 4 dose levels of study drug combination tested with 3-6 participants enrolled at each dose level. Erlotinib beginning dose of 150 mg taken by mouth daily for 21-day cycle. Bortezomib beginning dose of 1. mg/m\^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.
Drug: Erlotinib Hydrochloride · Drug: Bortezomib
Beginning dose of 150 mg taken by mouth daily for 21-day cycle.
Also known as: Erlotinib, Tarceva
Beginning dose of 1. mg/m\^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.
Also known as: Velcade, LDP-341, MLN341, PS-341
Tumor Response
Tumor response defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, (3) decrease in tumor markers by more than or equal to 25% (for example, a \>/= 25% decrease in cancer antigen 125 (CA125) for patients with ovarian cancer), or (4) a partial response according to the Choi criteria, i.e. decrease in size by 10% or more, or a decrease in the tumor density, as measured in Hounsfield units (HU), by more than or equal to 15%.
Time frame: Evaluation of response after two 21-day cycles of treatment
Maximum Tolerated Dose (MTD)
MTD defined as highest dose studied in which incidence of dose limiting toxicity (DLT) was less than 33%. DLT defined as any Grade 3 or 4 non-hematologic toxicity defined in the NCI CTC v3.0, even if expected and believed related to study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by the NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity, including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.
Time frame: 21 days
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
M.D. Anderson Cancer Center