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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01079481
First received: February 8, 2010
Last updated: May 29, 2013
Last verified: May 2013
  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 ]

Enrollment: 21
Study Start Date: December 2009
Study Completion Date: April 2013
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:

  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079481

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
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, Principal investigator, 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: May 29, 2013
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
Paclitaxel
Sirolimus
Everolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on September 16, 2014