A study to compare weekly Paclitaxel injection with best supportive care in patients with lung cancer

Phase 3

Conditions: Health Condition 1: null- Patients with small cell lung cancer relapsed on two or more lines of chemotherapy

Registration Number: CTRI/2018/04/013507

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 < 2

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) < 3 x upper limit of normal (ULN)

ii.Total bilirubin levels < 1.5 times ULN

iii.In patients with liver metastases, transaminases (AST and ALT) should be < 5 times ULN and bilirubin < 3 times ULN.

d.No contraindications to receiving chemotherapy.

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.