NCT00453167CompletedPhase 2
A Phase II Study of Weekly Paclitaxel and Gemcitabine as Second-line Therapy in Patients With Metastatic or Recurrence Small Cell Lung Cancer
National Cancer Center, Korea1 site in 1 country35 target enrollmentStarted: December 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- To evaluate the response rate of paclitaxel plus gemcitabine
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
study arm
Experimental
Intervention: Paclitaxel (Drug)
study arm
Experimental
Intervention: Gemcitabine (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Study Sites (1)
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