Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Stepwise titrated Conventional paclitaxel infusion schedule: Intravenous injection Dexamethasone (8mg - weekly, 12mg - 3 weekly) + Pheniramine 45.5mg + Ranitidine 50mg given 30-60 minut
Sponsors
NCI AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: Adults patients with age between 18 years to 70 years Histopathological diagnosis of cancer Willing to participate and to give written informed consent Naïve to conventional paclitaxel chemotherapy and planned to receive conventional paclitaxel either as single agent or in combination ECOG performance status 0-2 Stable baseline vital signs: Afebrile, radial artery blood pressure (90/60 â?? 130/90mm Hg), pulse rate 60 â?? 100 / minutes, respiratory rate 12-18/ minutes, 97.8 °F to 99.1 °F (36.5° C to 37.3° C);
Exclusion criteria
Exclusion criteria: Past history of hypersensitivity reaction to paclitaxel or cremophor containing drugs (cyclosporine, propofol, diazepam, teniposide, etoposide, Vitamin K) or partner drug or pheniramine or ranitidine On chronic systemic steroids or received any dose in the last week No history of hypersensitivity to partner drug Hb 2mg/dl, Bilirubin > 5 X ULN, transaminases 10 times or more
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the incidence of paclitaxel infusion related acute hypersensitivity reaction with stepwise titrated schedule compared to the standard scheduleTimepoint: On day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the incidence of minor and severe paclitaxel infusion related acute hypersensitivity reaction between the two arms To determine the risk factor associated with paclitaxel infusion related acute hypersensitivity reaction To determine the incidence of paclitaxel infusion related acute hypersensitivity reaction in the different paclitaxel dose schedule (50 â?? 80mg/m2, 175mg/m2) To compare the time to hypersensitivity reaction between the two study arms Timepoint: One day | — |
Countries
India
Contacts
Public ContactAkash Kumar
NCI AIIMS
Outcome results
None listed