Combination Anticancer Therapy of Paclitaxel and Everolimus for Relapsed or Refractory Small Cell Lung Cancer
This study is currently recruiting participants.
Verified July 2011 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01079481
First received: February 8, 2010
Last updated: July 21, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: taxol plus everolimus |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Samsung Medical Center:
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 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the safety when paclitaxel plus everolimus are given to patients with small cell lung cancer [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- To evaluate the objective response rate by RECIST 1.1 criteria [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079481
Contacts
| Contact: Keunchil Park, M.D., Ph.D | 822-3410-3450 | kpark@skku.edu |
Locations
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Keunchil Park, M.D., Ph.D 822-3410-3450 kpark@skku.edu | |
Sponsors and Collaborators
Samsung Medical Center
Investigators
| Principal Investigator: | Keunchil Park, M.D., Ph.D | Samsung Medical Center |
More Information
No publications provided
| Responsible Party: | Keunchil Park , M.D., Ph.D., Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01079481 History of Changes |
| Other Study ID Numbers: | 2008-10-034 |
| Study First Received: | February 8, 2010 |
| Last Updated: | July 21, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Samsung Medical Center:
|
Relapsed or Refractory Small Cell Lung Cancer Paclitaxel Everolimus |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Everolimus Sirolimus Paclitaxel Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013