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An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung


OBJECTIVES:

- Compare the overall survival of patients with chemotherapy-naive extensive stage small
cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide.

- Compare the response rates, response duration, and time to progression in patients
treated with these regimens.

- Compare the tolerability of these regimens in these patients.

- Compare the patient-perceived disease status and well being in patients treated with
these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to gender, ECOG performance status (0 vs 1 vs 2), lactate dehydrogenase (less than
1.5 times upper limit of normal (ULN) vs 1.5 times ULN or greater), and country. Patients
are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day
5.

- Arm II: Patients receive cisplatin IV on day 1 and etoposide IV over at least 30
minutes on days 1-3.

Treatment in both arms repeats every 21 days for at least 4 courses in the absence of
disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, prior to each course, at 4 weeks after study, and
then every 4 weeks for 16 weeks.

Patients are followed at 4 weeks, every 4 weeks for 16 weeks, and then every 3 months
thereafter.

PROJECTED ACCRUAL: Approximately 760 patients (380 per treatment arm) will be accrued for
this study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed extensive stage small cell lung carcinoma
(SCLC)

- No prior chemotherapy for SCLC OR

- No chemotherapy within 5 years of diagnosis of SCLC

- Prior radiotherapy to measurable or nonmeasurable disease field allowed provided
radiotherapy was completed at least 6 weeks ago and the disease is demonstrated to be
progressing

- No clinical signs or symptoms of brain and/or leptomeningeal metastases by CT scan or
MRI

- Brain and/or leptomeningeal metastases that are asymptomatic on neurologic exam
are allowed provided metastases do not require corticosteroid therapy to control
symptoms

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Hemoglobin at least 9.0 g/dL

- WBC at least 3,500/mm3

- Platelet count at least 100,000/mm3

- Neutrophil count at least 1,500/mm3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- SGOT and SGPT no greater than 2 times the upper limit of normal (ULN) (5 times ULN if
liver metastases present)

- Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastases
present)

Renal:

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- No pre-existing renal impairment that would preclude cisplatin use

Gastrointestinal:

- No clinical evidence of any gastrointestinal (GI) conditions including:

- Removal of a portion of the stomach

- History of recent obstruction of the GI tract

- GI autonomic neuropathy

- Ulcerative colitis

- Crohn's disease

- Malabsorption syndrome

- Treatment with cyclosporine that would alter absorption or GI motility

- No other conditions that would preclude absorption of oral topotecan

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for 3 months prior to study,
during, and for at least 1 month after study

- No active infection

- No other prior or concurrent malignancy within the past 5 years except adequately
treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or
localized low-grade prostate cancer

- No other concurrent severe medical problems that would expose the patient to extreme
risk or preclude study compliance

- No prior allergic reactions to compounds chemically related to study drugs

- No pre-existing hearing impairment that would preclude cisplatin use

- No overall medical condition for which study drugs would be inappropriate

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy for SCLC

Chemotherapy:

- See Disease Characteristics

- No other concurrent chemotherapy for SCLC

Endocrine therapy:

- See Disease Characteristics

- No concurrent hormonal therapy for SCLC

Radiotherapy:

- See Disease Characteristics

- At least 24 hours since prior radiotherapy with no expected bone marrow suppression

- Recovered from prior palliative radiotherapy (e.g, nausea and vomiting from radiation
of the epigastrium)

- No concurrent radiotherapy for SCLC

- No concurrent radiotherapy for palliation of bone metastases or CNS lesions unless
approved by the investigator

Surgery:

- At least 3 weeks since prior major surgery (a shorter period is allowed if deemed in
the best interest of the patient)

Other:

- More than 30 days or 5 half-lives (whichever is longer) since prior investigational
drugs

- No other concurrent investigational therapy for SCLC

- No concurrent cyclosporine

- No concurrent drugs that would preclude absorption of oral topotecan

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Nathan Levitan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069435

NCT ID:

NCT00041015

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065