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

Primary Purpose

Small Cell Lung Cancer

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

taxol plus everolimus

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Relapsed or Refractory Small Cell Lung Cancer, Paclitaxel, Everolimus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with histologically or cytologically confirmed small cell lung cancer
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.
Regarding an extensive disease, the progression/relapse of the disease during or after the first line platinum-based anticancer therapy should be confirmed.
Patient with asymptomatic or treated brain metastasis.
Patients without current concomitant chemotherapy
Patients without current concomitant radiotherapy
Patients who are not receiving chronic treatment with steroids or another immunosuppressive agent.
Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Patients aged 18 years or older
ECOG performance status 0-2
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.
Patients who signed and dated the informed consent form prior to specific study procedures.
Patients who can comply with the scheduled follow-up and toxicity management procedure.'

Exclusion Criteria:

Patients with history of treatment with mTOR inhibitors
Pregnant with gastrointestinal problem impairing absorption of drugs
Patients who could not use appropriate method of contraception
Pregnant or feeding patients
Other medically ill patients
Severe heart/pulmonary disease
DM patients
Other malignancy except cured skin cancer or uterine cervix carcinoma in situ
High cholesterolemia greater than grade 3
Patients with symptomatic brain metastasis
Chronic hepatitis or liver cirrhosis (patients with HBsAg positive, IgM anti-HBc positive or HCV Ab positive)
Patients receiving immunosuppressant

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

taxol plus everolimus

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate the safety when paclitaxel plus everolimus are given to patients with small cell lung cancer

To evaluate the objective response rate by RECIST 1.1 criteria

Full Information

NCT ID

NCT01079481

First Posted

February 8, 2010

Last Updated

May 29, 2013

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01079481

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

Keywords

Relapsed or Refractory Small Cell Lung Cancer, Paclitaxel, Everolimus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

taxol plus everolimus

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

taxol plus everolimus

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

To evaluate the safety when paclitaxel plus everolimus are given to patients with small cell lung cancer

Time Frame

18 months

Title

To evaluate the objective response rate by RECIST 1.1 criteria

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with histologically or cytologically confirmed small cell lung cancer 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. Regarding an extensive disease, the progression/relapse of the disease during or after the first line platinum-based anticancer therapy should be confirmed. Patient with asymptomatic or treated brain metastasis. Patients without current concomitant chemotherapy Patients without current concomitant radiotherapy Patients who are not receiving chronic treatment with steroids or another immunosuppressive agent. Patients with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST). Patients aged 18 years or older ECOG performance status 0-2 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. Patients who signed and dated the informed consent form prior to specific study procedures. Patients who can comply with the scheduled follow-up and toxicity management procedure.' Exclusion Criteria: Patients with history of treatment with mTOR inhibitors Pregnant with gastrointestinal problem impairing absorption of drugs Patients who could not use appropriate method of contraception Pregnant or feeding patients Other medically ill patients Severe heart/pulmonary disease DM patients Other malignancy except cured skin cancer or uterine cervix carcinoma in situ High cholesterolemia greater than grade 3 Patients with symptomatic brain metastasis Chronic hepatitis or liver cirrhosis (patients with HBsAg positive, IgM anti-HBc positive or HCV Ab positive) Patients receiving immunosuppressant

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keunchil Park, M.D., Ph.D

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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