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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Paclitaxel

Gemcitabine

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Small cell lung cancer, second-line therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

National Cancer Center, Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study arm

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the response rate of paclitaxel plus gemcitabine

Secondary Outcome Measures

To access the toxicity

To estimate the time to progression

To examine the association between genotypes of paclitaxel biotransformation and the pharmacokinetics /

To estimate the overall survival

Full Information

NCT ID

NCT00453167

First Posted

March 27, 2007

Last Updated

July 9, 2010

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00453167

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Small cell lung cancer, second-line therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

To evaluate the response rate of paclitaxel plus gemcitabine

Time Frame

the ratio between the number of responders and number of patients assessable for tumor response

Secondary Outcome Measure Information:

Title

To access the toxicity

Time Frame

the first day of the treatment to 30 days after the last dose of study drug

Title

To estimate the time to progression

Time Frame

the first day of treatment to the date that disease progression is reported

Title

To examine the association between genotypes of paclitaxel biotransformation and the pharmacokinetics /

Time Frame

before the first treatment date, each response evaluation until disease progression

Title

To estimate the overall survival

Time Frame

the first day of treatment to death date

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heung Tae Kim, M.D.

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center, Korea

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

411-769

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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