A Phase II Trial of High Dose Paclitaxel, Carboplatin and Topotecan With Peripheral Blood Stem Cell Support in Extensive Stage Small Cell Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma of Unknown Primary, Lung Cancer

Thank you

Trial Information

A Phase II Trial of High Dose Paclitaxel, Carboplatin and Topotecan With Peripheral Blood Stem Cell Support in Extensive Stage Small Cell Cancer


OBJECTIVES: I. Evaluate one year progression free survival, complete response rate, and
overall survival in patients with metastatic small cell cancer treated with high dose
paclitaxel, carboplatin, and topotecan with peripheral blood stem cell support. II. Assess
the safety of this treatment regimen in this patient population.

OUTLINE: Patients receive cyclophosphamide IV over 1 hour, followed by paclitaxel IV over 24
hours on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing
through the day prior to the last collection day. Peripheral blood stem cells (PBSC) are
collected over 3-5 days. Beginning approximately 21 days following mobilization, patients
receive paclitaxel IV over 24 hours on day 1, immediately followed by carboplatin IV over 2
hours and topotecan IV over 24 hours on day 2, then G-CSF subcutaneously beginning on day 4
and continuing until blood counts recover. PBSC are reinfused on day 5. Patients receive 1/3
of PBSC with each course. Treatment repeats every 4 weeks for 3 courses in the absence of
unacceptable toxicity. Patients are followed at week 8 after treatment, then every 3 months
for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed small cell carcinoma Any primary site or
unknown primary site Extensive or metastatic disease Lung primaries must have at least one
of the following: Contralateral hilar adenopathy Contralateral supraclavicular adenopathy
Malignant pleural effusion Distant metastases No brain metastases or CNS involvement
Stable or responding disease to prior standard therapy allowed Measurable or evaluable
disease prior to standard therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-1 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Transaminases no greater than 2
times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine
clearance at least 60 mL/min No overt renal failure Cardiovascular: Ejection fraction at
least 45% No myocardial infarction within past 6 months No congestive heart failure No
significant cardiac arrhythmia No poorly controlled hypertension Pulmonary: FEV1 and DLCO
at least 45% predicted No severe pulmonary disease Other: HIV negative No AIDS No other
prior or concurrent malignancies within the past 5 years except basal or squamous cell
skin cancer No severe medical illness (e.g., active peptic ulcer disease or brittle or
uncontrolled insulin dependent diabetes) No severe or uncontrolled psychiatric illness
(e.g., severe depression) No history of drug abuse Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception 3 months prior to, during
and 3 months after study No hypersensitivity to E. coli derivatives

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: 2 prior courses of
standard therapy of etoposide and a platinum analog required No other prior chemotherapy
Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 3 weeks
since prior major surgery

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the one year progression-free survival

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Russell J. Schilder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067136

NCT ID:

NCT00003943

Start Date:

September 1998

Completion Date:

February 2003

Related Keywords:

  • Carcinoma of Unknown Primary
  • Lung Cancer
  • extensive stage small cell lung cancer
  • newly diagnosed carcinoma of unknown primary
  • Carcinoma
  • Lung Neoplasms
  • Neoplasms, Unknown Primary

Name

Location
Johns Hopkins Oncology Center Baltimore, Maryland  21287
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111