Clinical trial NCT01079481: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Small Cell Lung Cancer
Keywords: Relapsed or Refractory Small Cell Lung Cancer
Paclitaxel
Everolimus
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: To determine the maximum tolerated dose (MTD) of everolimus when combined with fixed dose of paclitaxel in small cell lung cancer patients
timeFrame: 18 months
Secondary outcomes:
measure: To evaluate the safety when paclitaxel plus everolimus are given to patients with small cell lung cancer
timeFrame: 18 months
measure: To evaluate the objective response rate by RECIST 1.1 criteria
timeFrame: 18 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Keunchil Park, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: