Development and clinical activity of low dose metronomic chemotherapy with oral paclitaxel.
Recruiting
- Conditions
- Cancer, oral, paclitaxel, low dose metronomic, phase 1, kanker, oraal, laaggedoseerd, metronoom, fase 1
- Registration Number
- NL-OMON21795
- Lead Sponsor
- The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Patients with histological or cytological proof of cancer who might benefit from treatment with paclitaxel (excluding patients with secondary breast cancer metastasis with only lung metastases and primary brain tumors);
2. Patients for whom no standard therapy of proven benefit exist;
Exclusion Criteria
1. Patients with known alcoholism, drug addiction, psychotic disorders in the history and/or other reasons, for which they are not amenable for adequate follow up;
2. Women who are pregnant or breast feeding;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the safety and feasibility of LDM bi-daily oral paclitaxel (as ModraPac001 capsules) in combination with boosting agent ritonavir.
- Secondary Outcome Measures
Name Time Method 1. To determine the recommended dose (RD) of bi-daily oral paclitaxel in combination with ritonavir;<br /><br>2. To determine the maximal tolerated dose (MTD, or maximal safe dose) to assess the safety range;<br /><br>3. Pharmacokinetics of paclitaxel and ritonavir in this schedule;<br /><br>4. Usefulness and feasibility of exploratory biomarkers:<br /><br>A. Levels of CEC and CEP;<br /><br>B. Serum levels and gene expression of thrombospondin-1 (TSP-1);<br /><br>C. To preliminary asses the efficacy of LDM treatment, measured by PFS, response rates, duration of response and duration of disease control.<br /><br>5. To establish the effect of functional genetic polymorphisms in six genes (SLCO1B3, ABCB1, ABCC2, CYP3A4, CYP3A5 and CYP2C8 on the pharmacokinetics and pharmacodynamics of oral paclitaxel and ritonavir.