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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453167
• Other study ID #: NCCCTS-05-155
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: July 9, 2010
• Start date: December 2005
• Est. completion date: March 2010

Study information

• Verified date: July 2010
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Paclitaxel
Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
• Gemcitabine
Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the response rate of paclitaxel plus gemcitabine		the ratio between the number of responders and number of patients assessable for tumor response	No
Secondary	To access the toxicity		the first day of the treatment to 30 days after the last dose of study drug	Yes
Secondary	To estimate the time to progression		the first day of treatment to the date that disease progression is reported	No
Secondary	To examine the association between genotypes of paclitaxel biotransformation and the pharmacokinetics /		before the first treatment date, each response evaluation until disease progression	No
Secondary	To estimate the overall survival		the first day of treatment to death date	No