Weekly administration of oral docetaxel in combination with ritonavir for the treatment of a variety of tumour types

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 78

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, oesophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancers, prostate cancer and carcinoma of unknown primary site
4. Aged greater than or equal to 18 years
5. Able and willing to give written informed consent
6. Able and willing to undergo blood sampling for pharmacokinetics
7. Life expectancy greater than or equal to 3 months allowing adequate follow up of toxicity evaluation and anti-tumour activity
8. Minimal acceptable safety laboratory values
8.1. Absolute neutrophil count (ANC) of greater than or equal to 1.5 x 10^9/L
8.2. Platelet count of greater than or equal to 100 x 10^9/L
8.3. Hepatic function as defined by serum bilirubin less than or equal to 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN
8.4. Renal function as defined by serum creatinine less than or equal to 1.5 x ULN or creatinine clearance greater than or equal to 50 ml/min (by Cockcroft-Gault formula)
9. World Health Organisation (WHO) performance status of less than or equal to 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
12. Arm F: Patients for whom weekly paclitaxel can seriously be considered therapy with palliative intent, with tumour types 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 human immunodeficiency virus (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 (greater than grade 1) toxicities of previous chemotherapy
7. Bowel obstructions or motility disorders that may influence the resorption of drugs
8. Chronic use of H2-receptor antagonists or proton pump inhibitors
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: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials