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

NCT01079481 | Completed Phase 1

• 1 other identifier: 2008-10-034
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Keywords

Relapsed or Refractory Small Cell Lung Cancer; Paclitaxel; Everolimus

Outcome Measures

Primary Outcomes (1)

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

  18 months

Secondary Outcomes (2)

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

  18 months

• To evaluate the objective response rate by RECIST 1.1 criteria

  18 months

Study Arms (1)

taxol plus everolimus

EXPERIMENTAL

Drug: taxol plus everolimus

Interventions

taxol plus everolimus DRUG

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.

taxol plus everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.'

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Recurrence

Interventions

Paclitaxel; Everolimus

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Sirolimus; Macrolides; Lactones

Study Officials

• Keunchil Park, M.D., Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: March 3, 2010
• Study Start: December 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: April 1, 2013
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

KR (1)