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

Phase 1
18 Years
Not Enrolling
Small Cell Lung Cancer

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Trial Information

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

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.

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

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

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Keunchil Park, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center


Korea: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

April 2013

Related Keywords:

  • Small Cell Lung Cancer
  • Relapsed or Refractory Small Cell Lung Cancer
  • Paclitaxel
  • Everolimus
  • Lung Neoplasms
  • Small Cell Lung Carcinoma