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PHASE I EVALUATION OF TOPOTECAN IN COMBINATION WITH PACLITAXEL AND CARBOPLATIN


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

PHASE I EVALUATION OF TOPOTECAN IN COMBINATION WITH PACLITAXEL AND CARBOPLATIN


OBJECTIVES: I. Determine the maximum tolerated doses of combined topotecan, paclitaxel, and
carboplatin (TOPO/TAX/CBDCA) with or without filgrastim (G-CSF) in patients with advanced
solid tumors or lymphomas. II. Determine the toxic effects of this regimen in these
patients. III. Determine the pharmacokinetics of TOPO/TAX/CBDCA and whether TAX/CBDCA will
affect the pharmacokinetics of TOPO on day 1 as compared to TOPO administered alone on day
3. IV. Describe any clinical responses observed in these patients.

OUTLINE: This is a dose escalation study of the combination
topotecan/paclitaxel/carboplatin. Patients are stratified according to prior chemotherapy
and radiotherapy (yes vs no). Part I: Patients receive topotecan IV on days 1-3 and
paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes, on day 1. Part II:
Patients receive topotecan, paclitaxel, and carboplatin as in part I, plus filgrastim
(G-CSF) on days 6-19. Treatment repeats every 3 weeks in the absence of disease progression
or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of
topotecan/paclitaxel/carboplatin until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting
toxicity.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 4
years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven advanced solid tumor or lymphoma that is
refractory to standard therapy or for which no standard therapy exists or for which the
drugs used in this regimen constitute standard therapy Brain metastasis eligible provided:
Evidence of neurologic improvement or normalization No evidence of radiographic
progression after appropriate therapy Steroid dose stable (if given)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy:
Greater than 3 months Hematopoietic: Absolute granulocyte count at least 2,000/mm2
Platelet count at least 100,000/mm2 Hepatic: Bilirubin no greater than 1.5 mg/dL
Transaminases less than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within 6
months No history of congestive heart failure No uncontrolled angina No uncontrolled
arrhythmia Other: No concurrent medical illness or active infection that would render
treatment unsafe Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior topotecan,
paclitaxel, and carboplatin allowed if progression observed greater than 3 months after
last dose No prior mitomycin or nitrosoureas No more than 1 prior chemotherapy regimen At
least 4 weeks since chemotherapy and recovered (alopecia allowed) Endocrine therapy: Not
specified Radiotherapy: No prior radiotherapy to more than 25% of bone marrow At least 4
weeks since radiotherapy and recovered (alopecia allowed) Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064913

NCT ID:

NCT00005021

Start Date:

July 1996

Completion Date:

Related Keywords:

  • Lymphoma
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • small intestine lymphoma
  • unspecified adult solid tumor, protocol specific
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • intraocular lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111