Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma

NCT ID: NCT00055939

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2006-04-30

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating children who have relapsed or refractory rhabdomyosarcoma.

Detailed Description

OBJECTIVES:

• Determine the objective response rate (complete and partial responses) in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate.
• Determine the time to tumor progression in patients treated with this drug.
• Determine the median survival and survival at 6 and 12 months in patients treated with this drug.
• Assess pain in patients treated with this drug.
• Evaluate the quantitative and qualitative toxic effects of this drug in these patients.
• Evaluate the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 6 additional courses beyond CR.

PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study within 1 year.

Conditions

Sarcoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

exatecan mesylate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent or resistant rhabdomyosarcoma
• Measurable disease

• The following are not considered measurable disease:

• Ascites
• Pleural effusion
• Lytic bone lesions
• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• ECOG 0-2 (over 10 years old)
• Lansky 60-100% (10 years old and under)

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 750/mm^3
• Platelet count at least 75,000/mm^3
• Hemoglobin at least 8.5 g/dL

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• Albumin at least 2.8 g/dL
• AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)

Renal

• Creatinine no greater than 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No life threatening illness (unrelated to tumor) within the past 6 months
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No concurrent active serious infection
• No concurrent uncontrolled infection
• No overt psychosis or other incompetency that would preclude study compliance or giving informed consent
• No other concurrent noncancer-related illness that would preclude study participation or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 months since prior autologous bone marrow or stem cell transplantation
• No concurrent anticancer biologic therapy

Chemotherapy

• Recovered from prior adjuvant or systemic chemotherapy
• Prior topoisomerase I inhibitor therapy allowed
• No other concurrent anticancer chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior extensive radiotherapy to the cranial-spinal axis, whole pelvis, or 25% of marrow reserve
• No concurrent anticancer radiotherapy

Surgery

• At least 4 weeks since prior major surgery
• Recovered from prior surgery
• No concurrent anticancer surgery

Other

• At least 28 days since prior investigational drugs (including analgesics or antiemetics)
• No more than 2 prior regimens for rhabdomyosarcoma
• No concurrent grapefruit-containing beverages or foods
• No other concurrent investigational drugs during and for 28 days after final dose of study drug

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert L. DeJager, MD, FACP

Role: STUDY_CHAIR

Daiichi Sankyo

Locations

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, United States

Nemours Children's Clinic

Jacksonville, Florida, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Medical City Dallas Hospital

Dallas, Texas, United States

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

DAIICHI-8951A-PRT033

Identifier Type: -

Identifier Source: secondary_id

SJCRH-DXRMS

Identifier Type: -

Identifier Source: secondary_id

CDR0000271888

Identifier Type: -

Identifier Source: org_study_id