First-line Treatment Of Subjects With Extensive Disease Small Cell Lung Cancer With Weekly Hycamtin And Paraplatin

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316186
First received: April 19, 2006
Last updated: October 20, 2009
Last verified: October 2009
  Purpose

This study was designed to find the safest and most effective dose of a combination of two chemotherapy drugs, Hycamtin® (topotecan) and Paraplatin® (carboplatin), in people with extensive disease small cell lung cancer.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: topotecan
Drug: carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Phase II Study of Weekly Intravenous Hycamtin and Carboplatin as First-line Treatment of Chemonaive Subjects With Extensive Disease Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response [ Time Frame: Baseline until up to Day 169 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Response [ Time Frame: From start of treatment to evidence of partial or complete response ] [ Designated as safety issue: No ]
  • Response Duration [ Time Frame: From time of partial or complete response to disease progression/death ] [ Designated as safety issue: No ]
  • Time to Progression [ Time Frame: From start of treatment to disease progression/death ] [ Designated as safety issue: No ]
  • Overall Survival, Calculated as the Number of Subjects Who Died From the Start of Treatment Until Follow-up [ Time Frame: Week 1 up to maximum of Day 519 ] [ Designated as safety issue: No ]
  • Grade 1 (Mild) Hematological Toxicities [ Time Frame: Week 1 through Endpoint (variable based on disease progression or toxicity) ] [ Designated as safety issue: No ]
  • Grade 2 (Moderate) Hematological Toxicities [ Time Frame: Week 1 through Endpoint (variable based on disease progression or toxicity ] [ Designated as safety issue: No ]
  • Grade 3 (Severe) Hematological Toxicities [ Time Frame: Week 1 through Endpoint (variable based on disease progression or toxicity ] [ Designated as safety issue: No ]
  • Grade 4 (Life-threatening or Disabling) Hematological Toxicities [ Time Frame: Week 1 through Endpoint (variable based on disease progression or toxicity ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: June 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: topotecan Drug: carboplatin
    Other Names:
    • topotecan
    • carboplatin
  Eligibility

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

Inclusion criteria:

  • Adequate contraception methods include: systemic contraceptives or IUD for 3 months prior to start of the study medication or diaphragm plus spermicide; for males, condom plus spermicide; or total abstinence from sexual intercourse during the course of the study
  • Women of childbearing potential and sexually active males must practice or use an accepted and effective form of contraception
  • Subjects who present with CNS metastases are eligible, provided the attending physician ascertains that the metastases are controlled before the start of chemotherapy, and the subject is asymptomatic on neurologic exam and is not receiving corticosteroid therapy to control symptoms. Continued use of other anti-seizure medication is permitted
  • Free of active infection
  • At screening, a probable life expectancy of at least 3 months
  • No prior chemotherapy for SCLC or any chemotherapy within 5 years of the diagnosis of SCLC. Prior radiation to any symptomatic site is permitted provided that the indicator lesion site(s) are not irradiated, and radiation is completed before chemotherapy is started
  • Performance status ECOG 0-1
  • Adequate hematologic, renal and hepatic function •Hematologic: ANC 1500/mm3 [1.5 x 109/L], platelet count 100,000/L (100 x 109/L), hemoglobin 9.0 g/dL
  • Renal: Serum Creatinine ≤1.5mg/dL (133mol/L) and CrCl 60 ml/min (Cockroft-Gault) [Cockroft, 1976]

CrCl may be calculated using the Cockcroft-Gault formula:

CrCl (ml/min) = Q x (140-age [yr]) x body wt [kg] 72 x serum creatinine [mg/dl] Q = 0.85 for females Q = 1.0 for males CrCl (ml/min) = K x (140-age [yr]) x body wt [kg] Serum creatinine [mol/L] K = 1.0 for females K = 1.23 for males

  • Hepatic: Serum bilirubin (1.5 mg/dL), SGOT (AST), SGPT (ALT) and Alkaline Phosphatase 2 times the upper limit of normal (ULN) if liver metastases are absent by abdominal CT or MRI, or 5 times ULN if liver metastases are present
  • At least 18 years old
  • Written informed consent (subject's written understanding of and agreement to participate in this study.
  • Subject with histologically-confirmed extensive small cell lung cancer or unequivocally positive positive cytological evidence (sputum, at least two, or aspirate biopsy)
  • Presence of measurable disease according to World Health Organization (WHO)* criteria, as determined by diagnostic tests, including CT scan of the chest and abdomen, or MRI scan of the brain, or CXR, or PET CT, MRI, and/or CXR are the preferred diagnostic methods to evaluate disease during the course of this study. Use of positron-emission tomography (PET) is not required, but is permitted if it is the standard diagnostic tool employed by the institution. Measurable disease - Presence of at least one bidimensionally measurable, non-CNS lesion (indicator lesion). If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology • Measurable disease, either on CT or MRI scan, requires one diameter 1 cm and one diameter 2 cm. • Measurable disease on CXR requires both diameters 2 cm. • Palpable tumor masses that could not be evaluated radiologically require two diameters 2 cm
  • At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the subject).
  • Subjects with central nervous system metastases are eligible as long as the attending doctor determines that the metastases are under control before the start of chemotherapy, and the subject has no symptoms of spreading of disease to the brain, and is not receiving drugs called steroids to control the symptoms.
  • Laboratory criteria: Subjects must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion criteria:

  • Concurrent or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC. (Concurrent radiation for palliation of bone metastases and CNS lesions must be discussed with and approved by the GlaxoSmithKline Medical Monitor)
  • Concurrent severe medical problems other than the diagnosis of SCLC, which would significantly limit full compliance with the study or expose the patient to extreme risk
  • Concomitant malignancies or previous malignancies other than SCLC within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or localized low grade prostate cancer (contact GlaxoSmithKline Medical Monitor to discuss enrolment of subjects with low grade prostate cancer)
  • Present clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan, or corticosteroid treatment to control symptoms of brain metastases
  • Uncontrolled infection
  • Ongoing tumor or previous tumor other than lung cancer within the last 5 years.
  • Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids
  • Severe medical problems other than the diagnosis of SCLC that would limit the ability of the subject to follow study plan or that would expose the subject to extreme risk.
  • Ongoing or planned chemotherapy, immunotherapy, radiation treatment, or other experimental drug therapy for the treatment of SCLC.
  • Use of investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
  • Women who are pregnant or lactating.
  • Women who can become pregnant who refuse to practice an adequate form of birth control.
  • Subjects with history of allergic reaction to chemicals related to HYCAMTIN and PARAPLATIN.
  • Subjects with pre-existing heart disease, such as congestive heart failure, irregular heartbeats that require treatment, and heart attack within the last 3-months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316186

Locations
United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85712
United States, California
GSK Investigational Site
Sacramento, California, United States, 95819
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33486
GSK Investigational Site
Hollywood, Florida, United States, 33021
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
United States, Indiana
GSK Investigational Site
Munster, Indiana, United States, 46321
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10467
United States, Texas
GSK Investigational Site
Amarillo, Texas, United States, 79106
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23230
Poland
GSK Investigational Site
Poznan, Poland
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00316186     History of Changes
Other Study ID Numbers: 104864/903
Study First Received: April 19, 2006
Results First Received: April 29, 2009
Last Updated: October 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Lung cancer
small cell lung cancer
first-line
extensive disease
HYCAMTIN
chemonaive
untreated

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
Carboplatin
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014