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ZD0473 and Doxorubicin in Treating Patients With Advanced Solid Tumors or Lymphoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016172
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining ZD0473 and doxorubicin in treating patients who have advanced solid tumors or lymphoma.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: picoplatin
Phase I

MedlinePlus related topics:   Cancer    Fungal Infections    Hodgkin's Disease    Intestinal Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Picoplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I Study of ZD0473 and Doxil in Patients With Advanced Refractory Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   November 2000

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016172

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     David R. Spriggs, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068603, MSKCC-00044, NCI-G01-1942
First Received:   May 6, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00016172
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Sezary syndrome
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Duodenal Neoplasms
Mycoses
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Leukemia, B-cell, chronic
Doxorubicin
B-cell lymphomas
Leukemia, T-Cell
Gastrointestinal Neoplasms
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Hodgkin's disease
Gastrointestinal Diseases
Cutaneous T-cell lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Sezary Syndrome
Mycosis Fungoides
Lymphoma, B-Cell
Lymphoma, large-cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Jejunal Diseases
Therapeutic Uses
Antibiotics, Antineoplastic
Ileal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 19, 2008




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