Phase I interaction study of Docetaxel with supplementation of St. John*s wort or Echinacea

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Patients for whom treatment with docetaxel is considered to be of therapeutic benefit, e.g. advanced breast, gastric, esophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancer and prostate cancer
2. Histological or cytological proof of malignancy
3. Age >=18 years
4. Performance: WHO <= 2
5. Life expectancy > 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity
6. Minimal acceptable safety laboratory values:
a) ANC of >= 1.5 × 109/L
b) Platelet count of >= 100 × 109/L
c) Haemoglobin level of >= 6.0 mmol/L
(prior transfusion is permitted)
d) Hepatic function as defined by serum bilirubin <= 1.5 times the upper limit of normal (ULN), ALT and AST <= 2.5 times the ULN
e) Renal function as defined by serum creatinine <= 1.5 times ULN or creatinine clearance >= 50 mL/min (by Cockcroft-Gault formula)
7. Able and willing to swallow and retain oral medication.
8. Able and willing to undergo blood sampling for pharmacokinetics
9. Willing to comply to the protocol and to follow dietary restrictions
10. Written informed consent.

Exclusion Criteria

1. Any treatment with investigation drugs within 30 days before the start of the study
2. Patients with known alcoholism, drug addiction and/or a history of psychotic disorders that are not suitable for adequate follow up
3. Men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, contraceptive pill (female partner), abstinence from sexual intercourse, sterilisation of man or woman).
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 analogs, 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 obstruction or motility disorders that may influence the absorption 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. Use of herbal supplements, especially St. John*s wort or echinacea, within 6 weeks prior to study treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The most important parameter is the concentration of docetaxel and the course<br /><br>of this concentration with time in the presence or absence of St. John's Wort<br /><br>or echinacea </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are toxicities that patients experience from docetaxel in<br /><br>the presence or absence of St. John's Wort or echinacea </p><br>

Phase I interaction study of Docetaxel with supplementation of St. John*s wort or Echinacea

Recruitment & Eligibility

Study & Design

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