Health Condition 1: null- Histologically or cytologically confirmed malignancy of the Breast or Ovary with ECOG 0-1,Treatment planned with Paclitaxel at dose of 175mg perm2
Conditions
Interventions
Intervention1: Inj.Paclitaxel: 175mg/m2 to be administered over 3 hours every 21 days
Control Intervention1: Injection Paclitaxel: Prospective, open label, non randomized, comparative pharmacokinetic
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patient >= 18 years of age. 2. Written informed consent must be obtained prior to any study related procedures. 3. Life expectancy of at least 3 months. 4. Histologically or cytologically confirmed malignancy of the Breast or Ovary. 5. Treatment planned with Paclitaxel at a dose of 175mg/m2 to be administered over 3 hours. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 7. Adequate hematologic function (ANC � 1500 cells/µL: Hemoglobin � 9 gm/dl, Platelets � 1.0 lakh/mm3). 8. Adequate renal function (Serum creatinine � 1.5 x ULN, if creatinine more than 1.0 x ULN and less or equal to 1.5 x ULN, calculated creatinine clearance according to CKD-EPI formula should be equal or more than 40 ml/min). 9. Serum bilirubin � 1.0 x ULN, ALT � 2.5 x ULN, AST � 2.5 x ULN). If liver metastasis is present ALT � 5 x ULN, AST � 5 x ULN. 10. Female patients must have a negative serum pregnancy test at baseline (not applicable to patients with bilateral oophrectomy and/ or hysterectomy or to those patients who are > 1 year postmenopausal). 11. All patients of reproductive age group must agree to use of an approved form of contraception. 12. Should have completed at least 3 weeks from last chemotherapy. 13. Should have completed at least 6 weeks from last radiotherapy. 14. Previous radiotherapy site should have included
Exclusion criteria
Exclusion criteria: 1. Known allergy to taxanes. 2. Grade 2 or higher peripheral neuropathy (e.g. numbness, tingling and/or pain in distal extremities. 3. Symptomatic or clinically active CNS disease or metastatic lesions (prior radiotherapy to brain metastases is allowed). 4. Major surgery within last 4 weeks and end of prior radiotherapy within last 6 weeks. 5. Pregnant or breast feeding women. 6. Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease). 7. Any history of angina pectoris, coronary artery disease or cerebrovascular disease or transient ischemic attack. 8. Cardiac arrhythmia requiring medical therapy. 9. Known chronic infection with HIV, Hepatitis B and C. 10. Patients unwilling to comply with the study procedures. 11. Prior radiotherapy involving the entire pelvis. 12. Presence of third space fluid (ascitis or pleural effusion) which cannot be removed completely before the study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Study the pharmacokinetics of Paclitaxel in patients from different BMI groups after standard administration of chemotherapy. Difference in AUC between the two groupsTimepoint: Comparison of the pharmacokinetic data will be carried out by the difference in mean approach. A population PK analysis will be carried out involving all enrolled patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Variables affecting the clearance and Vd of paclitaxel would be determined using NONMEM 2. Toxicity will be reported as per CTCAE v 4.3 and analyzed descriptively. Timepoint: Clinical evaluation and toxicity assessment will be done on day8 day21 of all the enrolled patients | — |
Countries
India
Contacts
Public ContactDr J V Divatia
Tata Memorial Hospital
Outcome results
None listed