Dataset Information

Phase I-II Study of the Combination of Bevacizumab (rhuMAb VEGF) and Erlotinib (EGFR TKI) plus Oxaliplatin and Capecitabine (XELOX) in Patients with Metastatic Colorectal Cancer: XELOX-TARAV study

ABSTRACT: Primary objectives: First step: To determine the maximum tolerated dose (MTD), the dose-limiting toxicity (DLT) and the recommended dose of erlotinib in combination with fixed doses of bevacizumab, capecitabine, and oxaliplatin. Second step: To assess the preliminary antitumor activity in terms of overall response rate (complete and partial responses) of erlotinib in combination with bevacizumab, capecitabine, and oxaliplatin Primary endpoints: This is a phase I-II study. At each dose level (first step) will be treated a cohort of 3 consecutive patients. In absence of dose- limiting toxicity (DLT) we will proceed to the next dose-level. Each cycle of treatment will be repeated every three weeks and patients are scheduled to receive at least three courses of therapy at the same dose level. Escalation of the dose to the next higher level proceeds after all 3 patients received the first cycle of therapy with the preceding dose and have been observed for at least 21 days without evidence of a dose-limiting toxicity (DLT), as defined below. Drug-related toxicities will be evaluated during each cycle of therapy and graded according to the NCI Common Toxicity Criteria. A DLT is defined as any of the following events: grade 4 neutropenia, grade 4 thrombocytopenia; any drug-related nonhematological toxicity greater than or equal to grade 3 (except alopecia). At the occurrence of a DLT in three patients from any cohort, an additional three patients will be enrolled at the preceding dose level, which is then considered the maximum tolerated dose (MTD) and the recommended dose for further evaluation (second step).

DISEASE(S): Colon Cancer Metastatic,Patients With Metastatic Colorectal Cancer, Who Have Not Previously Received Systemic Treatment For Metastatic Disease.

PROVIDER: 2518758 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:<p>LGL leukemia can be divided into three subsets including the following: αβ or γδT-LGL and NK-LGL leukemia. All three subtypes will be enrolled using a two-stage design. The primary endpoint of the study is assessment of overall clinical response. Correlative laboratory studies will be performed aimed at determining the mechanism of response to treatment. Thirteen participants will be accrued in the first stage at a dose of 300 mg BID administered intermittently every other week (i.e., 7 days on and 7 days off). If there are two or more responders, the protocol will be extended to a second stage of the study and accrual will be extended to 25 evaluable participants. Allowing for 10% rate of ineligibility due to unexpected events and dropout, we will accrue 14 patients in the first stage and 27 patients in total. Participants that withdraw from the study for reason unrelated to toxicity, will be replaced. There are two potential stopping rules for toxicity.</p> <p>If 3 or more participants out of the 13 enrolled in the first stage experiences grade IV neurotoxicity, the study will be stopped due to excessive toxicity. Dose reductions have been incorporated for hematologic toxicity. Treatment of T and NK LGL leukemia with immunosuppressive agents such as low-dose methotrexate generally require from four to six months for a clinical response and sometimes much longer. Therefore, in participants who show clinical improvement with less than grade three toxicity, tipifarnib treatment will be continued for as many as four additional months (12 months total). After the first 8 months, response will be assessed. The protocol treatment will be discontinued in participants with progression of disease. A long-term follow up will be performed for five years in patients that receive a complete clinical response. The long-term follow up will consist of vital signs, weight, CBCs, serum chemistries, and physical examination at six month intervals.</p>

Dataset Information

Phase I-II Study of the Combination of Bevacizumab (rhuMAb VEGF) and Erlotinib (EGFR TKI) plus Oxaliplatin and Capecitabine (XELOX) in Patients with Metastatic Colorectal Cancer: XELOX-TARAV study

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