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A Phase I/II Study of Paclitaxel, Estramustine Phosphate, and Vinorelbine (PaclEVin)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I/II Study of Paclitaxel, Estramustine Phosphate, and Vinorelbine (PaclEVin)


OBJECTIVES: I. Establish the maximum tolerated doses (MTDs) and recommended Phase II doses
(RPTDs) of vinorelbine and paclitaxel when combined with a fixed dose of estramustine in
patients with advanced cancers or metastatic prostate cancer. II. Determine the toxicity
pattern of this regimen at the MTDs and at the RPTDs in these patients. III. Make
preliminary observations of antitumor activity in these patients treated with this regimen
as leads for the Phase II portion of this study. IV. Establish the efficacy of the RPTDs of
vinorelbine and paclitaxel when combined with estramustine in patients with prostate cancer
who fulfill the criteria for the Phase II portion of this study.

OUTLINE: This is a dose escalation, multicenter study of vinorelbine and paclitaxel.
Patients receive oral estramustine every 8 hours on days 0-2 and 7-9 and vinorelbine IV over
6-10 minutes immediately followed by paclitaxel IV over 1 hour on days 2 and 9. Courses
repeat every 21 days. Patients with complete response, partial response, or stable disease
continue treatment indefinitely in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of vinorelbine and paclitaxel
until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the
lowest dose at which 2 or more of 3-6 patients experience dose limiting toxicity. The
recommended Phase II dose of vinorelbine or paclitaxel is defined as the dose immediately
preceding the MTD.

PROJECTED ACCRUAL: A minimum of 12-16 patients will be accrued over 1 year for Phase I of
the study and a total of 14-25 patients will be accrued for Phase II of the study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Phase I: Histologically proven advanced cancer that has failed or
is not amenable to standard treatment Phase II: Histologically proven metastatic prostate
cancer as documented by bone scan and rising PSA Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not
specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hemoglobin greater than 9 g/dL (transfusion allowed) Hepatic: AST and ALT no
greater than 4 times upper limit of normal Bilirubin no greater than 2 mg/dL Renal:
Creatinine no greater than 2 mg/dL Cardiovascular: No myocardial infarction within the
past year No New York Heart Association class III or IV heart disease No uncontrolled
cardiac dysrhythmia No angina pectoris No uncontrolled hypertension No cardiomyopathy
Neurologic: No prior neuropathy No preexisting neurotoxicity Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Phase I: No prior
vinorelbine (any schedule) or paclitaxel on a 24 hour or longer schedule At least 2 weeks
since prior chemotherapy Phase II: No prior chemotherapy Endocrine therapy: Not specified
Radiotherapy: No radiotherapy to greater than 25% of bone marrow At least 3 weeks since
prior radiotherapy No concurrent radiotherapy during courses 1 and 2. Surgery: No
concurrent oncologic surgery during courses 1 and 2

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Franco M. Muggia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000067324

NCT ID:

NCT00004105

Start Date:

September 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Sarcoma
  • 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
  • unspecified adult solid tumor, protocol specific
  • childhood fibrosarcoma
  • 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
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • 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
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic
  • Sarcoma

Name

Location

NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016