Weekly administration of Oral Docetaxel in combination with Ritonavir

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

1. Histological or cytological proof of cancer;2. Patients for whom no standard therapy of proven benefit exist;3. Patients who might benefit from treatment with docetaxel, e.g. advanced breast, gastric, esophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancers, prostate cancer and carcinoma of unknown primary site. ;4. Age > 18 years;5. Able and willing to give written informed consent;6. Able and willing to undergo blood sampling for pharmacokinetics;7. Life expectancy > 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity;8. Minimal acceptable safety laboratory values;a. ANC of > 1.5 x 109 /L;b. Platelet count of > 100 x 109 /L;c. Hepd. Renal function as defined by serum creatinine < 1.5 x ULN or creatinine clearance > 50 ml/min (by Cockcroft-Gault formula).;9. WHO performance status of </= 2;10. No radio- or chemotherapy within the last 4 weeks prior to study entry (palliative limited radiation for pain reduction is allowed);11. Able and willing to swallow oral medication;atic function as defined by serum bilirubin < 1.5 x ULN, ALAT and ASAT < 2.5 x ULN;12. Arm F: Patients for whom weekly paclitaxel can seriously be considered therapy with palliative intent, with tumortypes that reasonably will respond.

Exclusion Criteria

1. Patients with known alcoholism, drug addiction and/or a history of psychotic disorders that are not suitable for adequate follow up;2. Women who are pregnant or breast feeding. ;3. Both men and women who do not agree to use a reliable contraceptive method throughout the study ;4. Concomitant use of MDR and CYP3A modulating drugs such as Ca¬¬+-entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications; other protease inhibitors, (non) nucleoside analoga, or St. Johns wort.;5. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients;6. Unresolved (>grade 1) toxicities of previous chemotherapy;7. Bowel obstructions or motility disorders that may influence the resorption of drugs;9. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity;10. Symptomatic cerebral or leptomeningeal metastases;11. Acid neutralizing medicines (e.g. aluminium hydroxide), should not be administered for at least 2 hours prior to and after the intake of ketoconazol (Arm D)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT),<br /><br>and optimal dose for oral docetaxel/ritonavir that can safely be administered<br /><br>to patients with cancer as monotherapy in a weekly schedule.</p><br>

Secondary Outcome Measures

Name	Time	Method

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