Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase I, and Biologic Correlative Study of Erlotinib, in Combination With Cetuximab and Bevacizumab in Patients With Metastatic Renal Cell Carcinoma
This randomized phase I/II trial studies the side effects, best way to give, and best dose of erlotinib and bevacizumab when given with cetuximab and how well giving erlotinib and cetuximab together with or without bevacizumab works in treating patients with metastatic or unresectable kidney, colorectal, head and neck, pancreatic, or non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with cetuximab and/or bevacizumab may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of erlotinib when combined with cetuximab in
patients with metastatic or unresectable renal cell, colorectal, head and neck, pancreatic,
or non-small cell lung cancer (part 1).
II. Determine the MTD of bevacizumab when combined with cetuximab and erlotinib in these
patients (part 2).
III. Determine the toxic effects, both quantitatively and qualitatively, of these regimens
in these patients.
IV. Determine the antitumor activity of these regimens, in terms of tumor response,
short-term survival, and progression-free survival, in these patients.
SECONDARY OBJECTIVES:
I. Compare, preliminarily, the toxicity and antitumor activity profiles of these regimens in
these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study of erlotinib and
bevacizumab.
Part 1: Patients receive oral erlotinib once daily on days 1-28. Patients also receive
cetuximab IV over 3 hours on day 1 and over 1 hour on days 8, 15, and 22.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Part 2: Patients receive erlotinib as in part 1 at the MTD and cetuximab as in part 1.
Patients also receive bevacizumab IV over 1½ hours on day 1 and over 1 hour on day 15.
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the MTD is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity.
In both groups, courses repeat every 28 days in the absence of unacceptable toxicity or
disease progression.
After completion of study treatment, patients are followed at 1 month.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01664754 -
Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT02451930 -
A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC
|
Phase 1 | |
| Withdrawn |
NCT02106559 -
Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy
|
N/A | |
| Completed |
NCT02364609 -
Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib
|
Phase 1 | |
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT01935336 -
Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers
|
Phase 2 | |
| Withdrawn |
NCT01971489 -
Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01839955 -
Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer
|
Phase 1 | |
| Terminated |
NCT01193868 -
RO4929097 in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Recently Completed Treatment With Front-Line Chemotherapy
|
Phase 2 | |
| Completed |
NCT00963807 -
Trial Comparing the Use of FLT PET to Standard CT to Assess Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable NSCLC
|
Phase 2 | |
| Completed |
NCT00986674 -
Carboplatin and Paclitaxel Combined With Cetuximab and/or IMC-A12 in Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT00085280 -
Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
|
N/A | |
| Completed |
NCT00087412 -
S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT00052338 -
Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT00006929 -
Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT02879994 -
Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Completed |
NCT03305380 -
Radiomics to Identify Patients at Risk for Developing Pneumonitis, Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and Distinguish Tumour Pseudo-progression From Real Tumour Growth
|
||
| Completed |
NCT02728596 -
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
|
N/A | |
| Active, not recruiting |
NCT02858869 -
Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases
|
Phase 1 | |
| Completed |
NCT02897375 -
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
|
Phase 1 |