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

NCT ID: NCT00453167

Last Updated: 2010-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2010-03-31

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

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study arm

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Interventions

Paclitaxel

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

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed SCLC

2. Clinically diagnosed metastatic or recurrent SCLC according to Sixth Edition of the AJCC Cancer Staging Manual

3. At least 18 years old

4. ECOG performance status 0-2

5. 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

6. Progression during or after prior first line chemotherapy or chemoradiotherapy.

7. Before study entry, a minimum of 21 days must have elapsed since any prior chemotherapy or radiation

8. No prior radiotherapy to measurable lesion(s) but previous surgery and/or chest radiotherapy for the primary lesion is allowed

9. 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

10. Patients should sign an informed consent

11. 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

1. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia

2. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy

3. Other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer

4. Pregnant or nursing women

5. Psychiatric disorder that would preclude compliance.

6. Major surgery other than biopsy within the past two weeks.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

National Cancer Center, Korea

Principal Investigators

Heung Tae Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCCCTS-05-155

Identifier Type: -

Identifier Source: org_study_id