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

Phase 1

Completed

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: taxol plus everolimus

• Registration Number: NCT01079481
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2012-05
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
taxol plus everolimus	taxol plus everolimus	-

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose (MTD) of everolimus when combined with fixed dose of paclitaxel in small cell lung cancer patients	18 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety when paclitaxel plus everolimus are given to patients with small cell lung cancer	18 months
To evaluate the objective response rate by RECIST 1.1 criteria	18 months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of