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

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: Paclitaxel Drug: Gemcitabine	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To access the toxicity [ Time Frame: the first day of the treatment to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
To estimate the time to progression [ Time Frame: the first day of treatment to the date that disease progression is reported ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To estimate the overall survival [ Time Frame: the first day of treatment to death date ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	December 2005
Study Completion Date:	March 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: study arm	Drug: Paclitaxel Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression Drug: Gemcitabine Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453167

Locations

Korea, Republic of
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769

Sponsors and Collaborators

National Cancer Center, Korea

Investigators

Principal Investigator:

Heung Tae Kim, M.D.

National Cancer Center, Korea

More Information

No publications provided

Responsible Party:	Heung Tae Kim, National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00453167 History of Changes
Other Study ID Numbers:	NCCCTS-05-155
Study First Received:	March 27, 2007
Last Updated:	July 9, 2010
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:

Small cell lung cancer
second-line therapy

Additional relevant MeSH terms:

Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013