Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C760- Malignant neoplasm of head, face and neck Health Condition 3: C61- Malignant neoplasm of prostate Health Condition 4: C169- Malignant neoplasm of stomach, unspecified Health Condition 5: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Injection Docetaxel: The dosing regimen for advanced breast cancer as monotherapy is 60 to 100 mg per m² IV over 1 hr q3Weeks or in combination therapy at a dose of 75 mg per m² IV 1
Sponsors
Advanced Cancer for Treatment Research and Education in cancer
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cytological or histological confirmed diagnosis of one of the aforementioned cancers 2. Patients advised docetaxel based chemotherapy and receiving first cycle of treatment 3. Aged 65 years and above 4. Adequate liver function defined as total bilirubin less or equal to 2 times upper limit of normal (ULN), SGOT and SGPT less or equal to 3 times ULN in the absence of liver metastasis and less or equal to 5 times ULN in the presence of liver metastasis 5. Haemoglobin greater or equal to 8 g per dL 7. ECOG PS less or equal to 2 8. Willing to consent for the study
Exclusion criteria
Exclusion criteria: 1. Patients on concomitant drugs which are cytochrome inducers or inhibitors, apart from those which are routinely prescribed along with chemotherapy (eg. Antiemetics and steroids are allowed). 2. Serious co-morbid conditions, including severe cancer cachexia, which in the opinion of the investigator may affect the disposition of drugs. 3. Patients with cancer cachexia (weight loss greater than 5%, or weight loss greater than 2% in individuals already showing depletion according to current body weight and height (BMI less than 20 kg per m2). 4. Patients with known brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development a PopPK model of docetaxel in geriatric patients (Age greater or equal to 65 years)Timepoint: Development a PopPK model of docetaxel in geriatric patients (Age greater or equal to 65 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Correlation between docetaxel disposition and response 2.Correlation between docetaxel disposition and toxicity 3. Identify the pharmacogenetic factors, co-variates which affect the inter-individual variability of docetaxel in geriatric patients Timepoint: 4 Years | — |
Countries
India
Contacts
Public ContactVikram Gota
Advanced Cancer for Treatment, Research and Education, Tata Momorial Centre
Outcome results
None listed