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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016172
• Other study ID #: 00-044
• Secondary ID: CDR0000068603NCI
• Status: Completed
• Phase: Phase 1
• First received: May 6, 2001
• Last updated: June 17, 2013
• Start date: November 2000
• Est. completion date: April 2002

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Small Intestine Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• pegylated liposomal doxorubicin hydrochloride

• picoplatin

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,