Weekly Paclitaxel Plus Gemcitabine as Second-line in Small Cell Lung Cancer

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Completed

CT.gov ID

NCT00453167

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

As a single agent, paclitaxel has a response rate of 33% and 25-29% in SCLC patients with sensitive relapse and with resistant relapse, respectively. As a single agent, gemcitabine also has a response rate 16% and 6-13% in SCLC patients with sensitive relapse and with resistant relapse, respectively. Because of single-agent activity, different mechanism of action, non-overlapping toxicities, and beneficial pharmacologic interaction, paclitaxel and gemcitabine combinations are attractive for testing in clinical trials.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Paclitaxel Drug: Gemcitabine	Phase 2

Detailed Description

The treatment consists of paclitaxel 80 mg/m2 and gemcitabine 1,000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle.

Patients receive treatment every 3 weeks till disease progression

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Weekly Paclitaxel and Gemcitabine as Second-line Therapy in Patients With Metastatic or Recurrence Small Cell Lung Cancer

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study arm	Drug: Paclitaxel Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression Drug: Gemcitabine Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression

Arm

Intervention/Treatment

Experimental: study arm

Drug: Paclitaxel

Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression

Drug: Gemcitabine

Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression

Outcome Measures

Primary Outcome Measures

To evaluate the response rate of paclitaxel plus gemcitabine [the ratio between the number of responders and number of patients assessable for tumor response]

Secondary Outcome Measures

To access the toxicity [the first day of the treatment to 30 days after the last dose of study drug]
To estimate the time to progression [the first day of treatment to the date that disease progression is reported]
To examine the association between genotypes of paclitaxel biotransformation and the pharmacokinetics / [before the first treatment date, each response evaluation until disease progression]
To estimate the overall survival [the first day of treatment to death date]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically or cytologically confirmed SCLC
Clinically diagnosed metastatic or recurrent SCLC according to Sixth Edition of the AJCC Cancer Staging Manual
At least 18 years old
ECOG performance status 0-2
Disease status must be that of measurable disease defined as RECIST:Lesions that can be accurately measured in at least one dimension > 10 mm with chest x-ray, spiral CT scan or physical examination
Progression during or after prior first line chemotherapy or chemoradiotherapy.
Before study entry, a minimum of 21 days must have elapsed since any prior chemotherapy or radiation
No prior radiotherapy to measurable lesion(s) but previous surgery and/or chest radiotherapy for the primary lesion is allowed
Adequate major organ function including the following:Hematologic function: WBC ≥ 3,500/mm3 or absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥ 100,000/mm3Hepatic function: bilirubin ≤ 1.5 x UNL , AST/ALT levels ≤ 2.5 x UNLRenal function: serum creatinine ≤ 1.5mg/dL
Patients should sign an informed consent
If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study registration.

Exclusion Criteria:

MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia
Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
Other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
Pregnant or nursing women
Psychiatric disorder that would preclude compliance.
Major surgery other than biopsy within the past two weeks.