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Initial Clinical Evaluation of the Combination of Paclitaxel and Carboplatin With Modulation of Toxicity With GCSF and Amifostine


Phase 1
N/A
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Initial Clinical Evaluation of the Combination of Paclitaxel and Carboplatin With Modulation of Toxicity With GCSF and Amifostine


OBJECTIVES: I. Establish the maximum tolerated dose of a paclitaxel and carboplatin
combination modulated by amifostine and filgrastim (G-CSF) in patients with recurrent or
metastatic cancer. II. Define the dose limiting toxicity of this combination in these
patients. III. Observe any antitumor responses in patients treated with this combination.

OUTLINE: This is a dose escalation study of paclitaxel. Patients receive a 10 minute
infusion of amifostine followed by paclitaxel given intravenously over 3 hours followed by
carboplatin given over 30 minutes. Filgrastim (G-CSF) is given subcutaneously daily for up
to 10 days by self administration starting the following day. Treatment repeats every 28
days for at least 3 courses unless disease progression or unacceptable toxicity occurs.
Patients who develop dose-limiting toxicity (DLT) on a given course receive one dose level
lower on the next and subsequent courses. Patients with stable disease may continue
treatment for as long as benefit is shown. In the absence of DLT in the first 3 patients
treated, subsequent cohorts of 3 patients each receive escalating doses of paclitaxel on the
same schedule. If DLT occurs in 1 of 3 patients at a given dose level, then 3 additional
patients are added at that dose. If DLT occurs in 1 additional patient, this dose is the
maximum tolerated dose (MTD); if DLT occurs in more than 2 patients, then 3 additional
patients are added at the previous dose. If DLT occurs in no more than 2 of 6 patients, this
dose is considered the MTD. At any dose, 3 cases of DLT leads to discontinuation of
recruitment at that dose.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study within 18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven recurrent or metastatic malignant disease
not amenable to curative surgery, radiotherapy, conventional chemotherapy, or
investigational therapy of higher priority Priority given to patients with lung cancer or
cancers with tumors easily available for biopsy No CNS disease unless stable post
radiation

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
At least 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than
1.5 mg/dL Creatinine clearance at least 50 mL/min Cardiovascular: Systolic blood pressure
at least 90 mm Hg No severe heart decompensation No clinically significant cardiac
arrhythmia on EKG No inability to tolerate bradycardia Other: No active, uncontrolled
infection No nonmalignant systemic disease Not pregnant or nursing Effective contraception
required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immune stimulating agents
Chemotherapy: At least 3 weeks since chemotherapy (6 weeks since nitrosourea or mitomycin)
and recovered No prior paclitaxel or carboplatin No concurrent chemotherapy Endocrine
therapy: No concurrent hormone therapy Radiotherapy: At least 3 weeks since radiotherapy
to major bone marrow bearing areas and recovered Concurrent radiotherapy allowed for vital
indications or pain relief Surgery: At least 3 weeks since surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gary N. Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066227

NCT ID:

NCT00003294

Start Date:

May 1997

Completion Date:

May 2004

Related Keywords:

  • Leukemia
  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • unspecified adult solid tumor, protocol specific
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • untreated hairy cell leukemia
  • progressive hairy cell leukemia, initial treatment
  • refractory hairy cell leukemia
  • chronic myelomonocytic leukemia
  • 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
  • prolymphocytic leukemia
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic 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
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263