- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00453167
Weekly Paclitaxel Plus Gemcitabine as Second-line in Small Cell Lung Cancer
July 9, 2010 updated by: National Cancer Center, Korea
A Phase II Study of Weekly Paclitaxel and Gemcitabine as Second-line Therapy in Patients With Metastatic or Recurrence Small Cell Lung Cancer
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769
- National Cancer Center, Korea
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study arm
|
Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
the ratio between the number of responders and number of patients assessable for tumor response
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To access the toxicity
Time Frame: the first day of the treatment to 30 days after the last dose of study drug
|
the first day of the treatment to 30 days after the last dose of study drug
|
To estimate the time to progression
Time Frame: the first day of treatment to the date that disease progression is reported
|
the first day of treatment to the date that disease progression is reported
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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
|
before the first treatment date, each response evaluation until disease progression
|
To estimate the overall survival
Time Frame: the first day of treatment to death date
|
the first day of treatment to death date
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heung Tae Kim, M.D., National Cancer Center, Korea
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
March 27, 2007
First Submitted That Met QC Criteria
March 27, 2007
First Posted (Estimate)
March 28, 2007
Study Record Updates
Last Update Posted (Estimate)
July 12, 2010
Last Update Submitted That Met QC Criteria
July 9, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
Other Study ID Numbers
- NCCCTS-05-155
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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