Health Condition 1: null- Patients with small cell lung cancer relapsed on two or more lines of chemotherapy
Conditions
Interventions
Intervention1: Weekly paclitaxel (Arm A): Paclitaxel will be administered at a dose of 80 mg/m2 in a glass bottle with non-PVC tubing. Pre-medications will include intravenous dexamethasone 8 mg, intr
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically proven SCLC 2.Age over 18 years 3.Patient should have received at least two lines of systemic therapy and therapy should have been stopped due to progressive disease or intolerable side-effects. Chemotherapy received concurrently with radiotherapy may be considered as one line of systemic therapy. 4.Eastern cooperative oncology group (ECOG) performance status 5.Willing to provide written, informed consent. 6.Baseline laboratory parameters within acceptable limits, including a.Hemoglobin > 8 g/dl b.Absolute neutrophil count > 1.5 x 10e9/L and total leucocyte counts > 3.5 x 10e9/L c.Baseline liver function tests: i.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ii.Total bilirubin levels iii.In patients with liver metastases, transaminases (AST and ALT) should be d.No contraindications to receiving chemotherapy.
Exclusion criteria
Exclusion criteria: 1.Serious co-morbidities such as, but not limited to severe cardiac failure or severe pulmonary compromise or severe and active infections. 2.Peripheral neuropathy > grade 2. 3.Patient has received paclitaxel chemotherapy. 4.Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. The presence of a curatively treated malignancy for which the patient has completed therapy at least 3 years ago and is now in remission for, is considered acceptable. 5.Patients on other investigational drugs within the last 30 days. 6.Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median overall survivalTimepoint: Patients will be evaluated every 2 months until death. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the progression free survival (PFS), toxicity and quality of life (QoL) Side EffectsTimepoint: Progression free survival: Patients will be evaluated every 2 months until disease progression. QOL: Baseline , At 7-10 days after starting chemotherapy, Every 2 months, while the patient is on the active portion of the trial,At the completion of active portion of the trial side Effects:Will be evaluated every week months in Arm A and every 2 weeks in Arm B, until disease progression. | — |
Countries
India
Contacts
Public ContactDr Vanita Noronha
TATA MEMORIAL HOSPITAL
Outcome results
None listed