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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

Phase 2
18 Years
Not Enrolling
Small Cell Lung Cancer

Thank you

Trial Information

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

Inclusion 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

- 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

- Subjects with history of allergic reaction to chemicals related to HYCAMTIN and

- Subjects with pre-existing heart disease, such as congestive heart failure, irregular
heartbeats that require treatment, and heart attack within the last 3-months.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Baseline until up to Day 169

Safety Issue:


Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

May 2008

Related Keywords:

  • Small Cell Lung Cancer
  • Lung cancer
  • small cell lung cancer
  • first-line
  • extensive disease
  • chemonaive
  • untreated
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



GSK Investigational Site Phoenix, Arizona  85013 - 4496
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Indianapolis, Indiana  46260
GSK Investigational Site New Orleans, Louisiana  70112
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Park Ridge, Illinois  60068
GSK Investigational Site Salem, Virginia  24153
GSK Investigational Site New York, New York  10021