Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055939

Purpose

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.

Condition	Intervention	Phase
Sarcoma	Drug: exatecan mesylate	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric Patients With Relapsed Or Refractory Rhabdomyosarcoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Exatecan Exatecan mesylate

U.S. FDA Resources

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

Study Start Date:

January 2003

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055939

Locations

United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80218
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9063
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

Daiichi Sankyo Inc.

Investigators

Study Chair:

Robert L. DeJager, MD, FACP

Daiichi Sankyo Inc.

More Information

Additional Information:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00055939 History of Changes
Other Study ID Numbers:	CDR0000271888, DAIICHI-8951A-PRT033, SJCRH-DXRMS
Study First Received:	March 6, 2003
Last Updated:	July 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

previously treated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma

Additional relevant MeSH terms:

Rhabdomyosarcoma
Sarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Exatecan
Camptothecin

Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012