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Phase II Study of Sequential Topotecan-Carboplatin-Etoposide in Patients With Extensive Stage Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase II Study of Sequential Topotecan-Carboplatin-Etoposide in Patients With Extensive Stage Small Cell Lung Cancer


OBJECTIVES:

- Determine the toxicity profile and maximum tolerated dose of sequential topotecan,
carboplatin, and etoposide in patients with chemotherapy-naive extensive stage small
cell lung cancer. (Phase I closed to accrual as of 04/04/2003).

- Determine the response rate and duration of response in patients with treated with this
regimen.

- Determine the failure-free and overall survival of patients treated with this regimen.

- Determine the pharmacokinetics and pharmacodynamics of topotecan and etoposide on this
schedule in these patients.

OUTLINE: This is a dose-escalation, multicenter study of topotecan and etoposide. (Phase I
closed to accrual as of 04/04/2003).

Patients receive oral topotecan on days 1-5, carboplatin IV over 30 minutes on day 6, and
oral etoposide on days 6-10. Treatment continues every 3 weeks for 2 courses in the absence
of disease progression or unacceptable toxicity. Patients with complete response (CR) or
partial response after the second course receive up to 4 additional courses. Patients with
brain metastases at initial presentation undergo whole-brain irradiation before the
chemotherapy regimen. Patients without brain metastases at initial presentation who achieve
CR undergo prophylactic whole-brain irradiation.

Sequential dose escalation of topotecan is followed by sequential dose escalation of
etoposide. Cohorts of 3-6 patients receive escalating doses of topotecan and then etoposide
until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined
as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting
toxicity. (Phase I closed to accrual as of 04/04/2003). In the phase II part of study, an
additional 11-40 patients are accrued to receive topotecan, carboplatin, and etoposide at
the MTD.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A maximum of 50 patients (3-10 for phase I and 11-40 for phase II) will
be accrued for this study. (Phase I closed to accrual as of 04/04/2003)

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed extensive stage small cell lung cancer

- Measurable or evaluable disease

- Pleural effusions allowed, but not considered measurable or evaluable disease

- Brain metastases allowed provided neurologically stable at study entry

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- More than 2 months

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

Renal:

- Creatinine no greater than 1.5 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to swallow capsules

- No concurrent or prior malignancy within the past 5 years except inactive
nonmelanomatous skin cancer or carcinoma in situ of the cervix

- No other serious medical or psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Prior radiotherapy for brain metastasis allowed

- No other prior radiotherapy

- No other concurrent radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Antonius A. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000068945

NCT ID:

NCT00025272

Start Date:

November 2001

Completion Date:

Related Keywords:

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

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - GreenvilleGreenville, South Carolina  29615
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534