Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors
Unspecified Adult Solid Tumor, Protocol Specific
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study To Determine The Safety, Tolerance And Preliminary Antineoplastic Activity Of Combined EGFR (erbB1) And HER2 (erbB2) Blockade, With OSI-774 And Trastuzumab, In Combination With Weekly Paclitaxel|
- Maximally tolerated dose (MTD), graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to day 28 ] [ Designated as safety issue: Yes ]
- Response rates, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
- Incidence of adverse events, graded according to the NCI CTC v2.0 [ Time Frame: Up to 30 days after last study treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2002|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (paclitaxel, trastuzumab, erlotinib hydrochloride)
See detailed description.
Other Names:Biological: trastuzumab
Other Names:Drug: erlotinib hydrochloride
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studies
I. Determine the safety, quantitative and qualitative toxic effects, maximum tolerated dose, and dose-limiting toxic effects of erlotinib when combined with paclitaxel and trastuzumab (Herceptin) in patients with advanced solid tumors.
II. Determine the relevant pharmacokinetic interactions between these agents in these patients.
III. Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of erlotinib.
Intermittent schedule: Patients receive paclitaxel IV over 1 hour followed 30 minutes later by trastuzumab (Herceptin) IV over 30 minutes on days 1, 8, and 15 of each course. Patients also receive oral erlotinib once daily on days 3-28 of course 1 and on days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Continuous schedule: Once the MTD is determined using the intermittent schedule, an additional 12 patients are accrued to study the tolerability of a continuous schedule comprising paclitaxel and trastuzumab as above on days 1, 8, 15, and 22 and oral erlotinib once daily on days 3-28 during course 1 and on days 1-28 of subsequent courses using the same dose-escalation scheme as above. Courses repeat as above.
Patients are followed every 30 days.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 10-13.3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042809
|United States, Texas|
|Cancer Therapy and Research Center at The UT Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Muralidhar Beeram||Cancer Therapy and Research Center at The UT Health Science Center at San Antonio|