Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055939
• Other study ID #: CDR0000271888
• Secondary ID: DAIICHI-8951A-PR
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2003
• Last updated: May 15, 2012
• Start date: January 2003
• Est. completion date: April 2006

Study information

• Verified date: May 2012
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhabdomyosarcoma
• Sarcoma

Intervention

Drug:
• exatecan mesylate

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
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 Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Countries where clinical trial is conducted

United States,  Canada,