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A Phase I Study of ZD0473 and Doxil in Patients With Advanced Refractory Cancer


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

A Phase I Study of ZD0473 and Doxil in Patients With Advanced Refractory Cancer


OBJECTIVES: I. Determine the maximum tolerated dose of ZD0473 and doxorubicin HCl liposome
in patients with advanced or metastatic solid tumors or lymphoma. II. Determine the
qualitative and quantitative toxic effects of this regimen in this patient population. III.
Determine the pharmacokinetics of these drugs in this patient population. IV. Determine the
antitumor activity of this regimen in this patient population.

OUTLINE: This is a dose-escalation study. Patients receive doxorubicin HCl liposome IV over
60 minutes followed by ZD0473 IV over 60 minutes on day 1. Treatment repeats every 28 days
for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with partial response (PR) or complete response (CR) may continue treatment until
disease progression or until 2 courses after maximum response. Cohorts of 3-6 patients
receive escalating doses of doxorubicin HCl liposome and ZD0473 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients
experience dose-limiting toxicity. Patients are followed at 4 weeks and 3 months. Patients
with PR or CR ongoing continue follow-up every 3 months until relapse.

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

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic solid tumors or
lymphoma Refractory to standard curative therapy OR No curative therapy exists
Serologically, clinically, and/or radiographically assessable disease No newly diagnosed
brain metastases Intracranial disease that is stable for at least 6 months allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST or
ALT no greater than 2.0 times ULN Alkaline phosphatase no greater than 2.0 times ULN
Renal: Creatinine no greater than ULN Creatinine clearance at least 60 mL/min
Cardiovascular: Ejection fraction at least 50% Other: No underlying medical condition that
would preclude study or that is uncontrolled No active serious infection No neurotoxicity
or preexisting grade 3 or higher neuropathy Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 5 days since prior immunotherapy
Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and
similar compounds) No more than 3 prior chemotherapy regimens for metastatic disease No
prior anthracycline exposure exceeding 300 mg/m2 doxorubicin No prior doxorubicin HCl
liposome Endocrine therapy: At least 5 days since prior hormonal therapy Radiotherapy: At
least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to more than
30% of functioning bone marrow Surgery: At least 3 weeks since prior major surgery Other:
No other concurrent experimental drugs No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David R. Spriggs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-044

NCT ID:

NCT00016172

Start Date:

November 2000

Completion Date:

April 2002

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

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021