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

NCT00453167 | Completed Phase 2

• 1 other identifier: NCCCTS-05-155
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Small cell lung cancer; second-line therapy

Outcome Measures

Primary Outcomes (1)

• To evaluate the response rate of paclitaxel plus gemcitabine

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

Secondary Outcomes (4)

• 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

Study Arms (1)

study arm

EXPERIMENTAL

Drug: Paclitaxel; Drug: Gemcitabine

Interventions

Paclitaxel DRUG

Paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks until disease progression

study arm

Gemcitabine DRUG

Gemcitabine 1000mg/m2 iv on day 1 and 8, every 3 weeks until disease progression

study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Heung Tae Kim, M.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: December 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: July 12, 2010

Record last verified: 2010-07

Locations

KR (1)