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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

Phase 2
Not Enrolling

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Trial Information

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


- 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.

Inclusion Criteria


- 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



- 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


- Absolute neutrophil count at least 750/mm^3

- Platelet count at least 75,000/mm^3

- Hemoglobin at least 8.5 g/dL


- 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)


- Creatinine no greater than 1.5 times ULN


- 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


Biologic therapy

- At least 3 months since prior autologous bone marrow or stem cell transplantation

- No concurrent anticancer biologic therapy


- Recovered from prior adjuvant or systemic chemotherapy

- Prior topoisomerase I inhibitor therapy allowed

- No other concurrent anticancer chemotherapy

Endocrine therapy

- Not specified


- More than 4 weeks since prior extensive radiotherapy to the cranial-spinal axis,
whole pelvis, or 25% of marrow reserve

- No concurrent anticancer radiotherapy


- At least 4 weeks since prior major surgery

- Recovered from prior surgery

- No concurrent anticancer surgery


- At least 28 days since prior investigational drugs (including analgesics or

- 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

Type of Study:


Study Design:

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

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.


United States: Federal Government

Study ID:




Start Date:

January 2003

Completion Date:

April 2006

Related Keywords:

  • Sarcoma
  • previously treated childhood rhabdomyosarcoma
  • recurrent childhood rhabdomyosarcoma
  • Rhabdomyosarcoma
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Medical City Dallas Hospital Dallas, Texas  75230
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Nemours Children's Clinic Jacksonville, Florida  32207
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390-9063