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

NCT ID: NCT01079481

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-04-30

Brief 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.

Detailed 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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

taxol plus everolimus

Group Type: EXPERIMENTAL

taxol plus everolimus

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Keunchil Park

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keunchil Park, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2008-10-034

Identifier Type: -

Identifier Source: org_study_id