Adult Solid Neoplasm Clinical Trial
Official title:
Phase I Trial of OSI-774 and CPT-11 in Patients With Advanced Solid Tumors
Phase I trial to study the effectiveness of combining erlotinib hydrochloride with irinotecan hydrochloride in treating patients who have advanced solid tumors. Erlotinib hydrochloride may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib hydrochloride and chemotherapy may kill more tumor cells.
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of erlotinib (erlotinib hydrochloride) and irinotecan (irinotecan hydrochloride), in relation to presence or absence of UGT1A1*28 polymorphism, in patients with advanced solid tumors that overexpress epidermal growth factor receptor. II. Determine the dose-limiting toxicity of these regimens in these patients. III. Determine whether erlotinib alters the disposition of irinotecan using a previously described limited sampling model. IV. Determine factors that influence the disposition of these drugs, including genetic variation in UGT1A1 and BCRP, in patients treated with these regimens. V. Determine factors that influence the disposition of these drugs, in terms of tumor BCRP-expression, in tumor samples from patients treated with these drugs at the MTD. VI. Evaluate the effect of this regimen on epidermal growth factor receptor phosphorylation in these patients. VII. Assess, preliminarily, any antitumor activity in patients treated with these regimens. VIII. Correlate, preliminarily, EGFR phosphorylation and/or BCRP -expression with response in tumor samples from these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to UGTA1A genotype (all patients regardless of genotype [closed to accrual as of 9/15/04] vs UGT1A1 6/6 genotype vs UGTA1A 6/7 or 7/7 genotype). Patients receive oral erlotinib hydrochloride daily on days -6 to -1. Patients then receive irinotecan hydrochloride intravenously (IV) over 90 minutes on day 1 and oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients per stratum receive escalating doses of erlotinib hydrochloride and irinotecan hydrochloride until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD. Patients are followed for 3 months. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT01971489 -
Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Terminated |
NCT01093092 -
Calcitriol, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors That Cannot Be Removed by Surgery
|
Phase 1 | |
Completed |
NCT01218620 -
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT00535119 -
Veliparib, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Cancer
|
Phase 1 | |
Completed |
NCT00070252 -
Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT02107443 -
Improving Communication in Older Cancer Patients and Their Caregivers
|
N/A | |
Completed |
NCT00608361 -
Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery
|
Phase 1 | |
Completed |
NCT01061749 -
Selumetinib and Cixutumumab in Treating Patients With Advanced Solid Malignancies
|
Phase 1 | |
Completed |
NCT00410553 -
Eribulin Mesylate and Gemcitabine Hydrochloride in Treating Patients With Metastatic Solid Tumors or Solid Tumors That Cannot be Removed by Surgery
|
Phase 1 | |
Completed |
NCT00499135 -
Sunitinib Malate in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01625156 -
Tivantinib and Temsirolimus in Treating Patients With Solid Tumors That is Metastatic or Cannot be Removed by Surgery
|
Phase 1 | |
Completed |
NCT01154426 -
ABT-888 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01131234 -
Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT02116777 -
Talazoparib and Temozolomide in Treating Younger Patients With Refractory or Recurrent Malignancies
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00878163 -
GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery
|
Phase 1 | |
Withdrawn |
NCT02627430 -
Talazoparib and HSP90 Inhibitor AT13387 in Treating Patients With Metastatic Advanced Solid Tumor or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple Negative Breast Cancer
|
Phase 1 | |
Completed |
NCT01548482 -
Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
Active, not recruiting |
NCT01375829 -
Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
Completed |
NCT00217373 -
Vaccine Therapy, GM-CSF, and Interferon Alfa-2b in Treating Patients With Locally Advanced or Metastatic Cancer That Expresses Carcinoembryonic Antigen (CEA)
|
Phase 1 | |
Active, not recruiting |
NCT02432963 -
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
|
Phase 1 |