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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the response rate of paclitaxel plus gemcitabine

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Heung Tae Kim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

December 2005

Completion Date:

March 2010

Related Keywords:

  • Lung Cancer
  • Small cell lung cancer
  • second-line therapy
  • Lung Neoplasms
  • Small Cell Lung Carcinoma