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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01079481
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
Keunchil Park, 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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: taxol plus everolimus Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer
Study Start Date : December 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: taxol plus everolimus 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.

Primary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD) of everolimus when combined with fixed dose of paclitaxel in small cell lung cancer patients [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. To evaluate the safety when paclitaxel plus everolimus are given to patients with small cell lung cancer [ Time Frame: 18 months ]
  2. To evaluate the objective response rate by RECIST 1.1 criteria [ Time Frame: 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01079481

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: Keunchil Park, M.D., Ph.D Samsung Medical Center
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Responsible Party: Keunchil Park, Principal investigator, Samsung Medical Center Identifier: NCT01079481    
Other Study ID Numbers: 2008-10-034
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013
Keywords provided by Keunchil Park, Samsung Medical Center:
Relapsed or Refractory Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs