Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

A Phase I Study of Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079481
• Other study ID #: 2008-10-034
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2010
• Last updated: May 29, 2013
• Start date: December 2009
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this phase I study is to determine the maximum tolerated dose (MTD) of combination therapy of paclitaxel and everolimus in small cell lung cancer patient with previous treatment history.

Description:

Small cell lung cancer (SCLC) accounts for 15% to 20% of all lung cancer, and more than half of these patients are diagnosed with extensive-stage disease (ED). SCLC is a particularly aggressive form of lung cancer with a tendency for rapid tumor growth, early dissemination and high frequency of the metastasis In this study, we evaluate the MTD of everolimus combined with paclitaxel combination chemotherapy in SCLC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with histologically or cytologically confirmed small cell lung cancer

2. Regarding a limited disease, the disease in a patient, who had concurrent chemoradiation therapy before, is relapsed or progressing, the patient should have received the first line platinum-based anticancer therapy. The disease should be progressing/relapsed during or after the previous treatment.

3. Regarding an extensive disease, the progression/relapse of the disease during or after the first line platinum-based anticancer therapy should be confirmed.

4. Patient with asymptomatic or treated brain metastasis.

5. Patients without current concomitant chemotherapy

6. Patients without current concomitant radiotherapy

7. Patients who are not receiving chronic treatment with steroids or another immunosuppressive agent.

8. Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST).

9. Patients aged 18 years or older

10. ECOG performance status 0-2

11. Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; hemoglobin > 9g/dL; -; total bilirubin =1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance = 50mL/min.

12. Patients who signed and dated the informed consent form prior to specific study procedures.

13. Patients who can comply with the scheduled follow-up and toxicity management procedure.'

Exclusion Criteria:

1. Patients with history of treatment with mTOR inhibitors

2. Pregnant with gastrointestinal problem impairing absorption of drugs

3. Patients who could not use appropriate method of contraception

4. Pregnant or feeding patients

5. Other medically ill patients

6. Severe heart/pulmonary disease

7. DM patients

8. Other malignancy except cured skin cancer or uterine cervix carcinoma in situ

9. High cholesterolemia greater than grade 3

10. Patients with symptomatic brain metastasis

11. Chronic hepatitis or liver cirrhosis (patients with HBsAg positive, IgM anti-HBc positive or HCV Ab positive)

12. Patients receiving immunosuppressant

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• taxol plus everolimus
taxol 175mg/m2 every 3 weeks plus everolimus every day. The dose of everolimus will be started from 2.5mg per day, and increasing to 5mg per day and to 10mg per day.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose (MTD) of everolimus when combined with fixed dose of paclitaxel in small cell lung cancer patients		18 months	Yes
Secondary	To evaluate the safety when paclitaxel plus everolimus are given to patients with small cell lung cancer		18 months	Yes
Secondary	To evaluate the objective response rate by RECIST 1.1 criteria		18 months	No