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Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group


Phase 2
15 Years
75 Years
Not Enrolling
Both
Sarcoma

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Trial Information

Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group


OBJECTIVES:

- Determine the anticancer activity of exatecan mesylate, in terms of objective response
and duration of response, in patients with advanced soft tissue sarcoma.

- Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to histological
diagnosis (leiomyosarcoma vs other histologies).

Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression. After disease progression,
patients are followed every 12 weeks for survival.

PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed soft tissue sarcoma

- Malignant fibrous histiocytoma

- Liposarcoma

- Rhabdomyosarcoma

- Synovial sarcoma

- Malignant paraganglioma

- Fibrosarcoma

- Leiomyosarcoma

- Angiosarcoma including hemangiopericytoma

- Malignant peripheral nerve sheath tumor

- Unclassified sarcoma

- Miscellaneous sarcoma including mixed mesodermal tumors of the uterus

- The following tumor types are excluded:

- Gastrointestinal stromal tumor

- Chondrosarcoma

- Malignant mesothelioma

- Neuroblastoma

- Osteosarcoma

- Ewing's sarcoma

- Embryonal rhabdomyosarcoma

- Prior chemotherapy for metastatic disease required

- One line of combination chemotherapy containing anthracycline OR

- No more than 2 single-agent regimens including anthracycline

- Adjuvant chemotherapy not considered first line unless tumor progresses within 6
months after treatment

- Must have 1 measurable lesion

- Clinical evidence of progression within 6 weeks prior to study

- Osseous lesions and pleural effusions not considered measurable

- No known or symptomatic CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 15 to 75

Performance status:

- WHO 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 4,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.8 mg/dL

- Albumin at least 2.5 g/dL

Renal:

- Creatinine no greater than 1.4 mg/dL OR

- Creatinine clearance greater than 65 mL/min

Cardiovascular:

- No history of severe cardiovascular disease

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 6 months after
study participation

- No other severe medical illness, including psychosis

- No other prior or concurrent malignancy except adequately treated basal cell skin
cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- More than 4 weeks since prior chemotherapy

- No other concurrent cytotoxic therapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No radiotherapy to the sole measurable lesion

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- No other investigational drugs for 28 days prior to, during, and for 28 days after
completion of study drug

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Peter Reichardt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

Authority:

United States: Federal Government

Study ID:

EORTC-62006

NCT ID:

NCT00041236

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Sarcoma
  • adult angiosarcoma
  • adult fibrosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • adult neurofibrosarcoma
  • adult synovial sarcoma
  • stage IV adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • adult malignant fibrous histiocytoma
  • adult malignant hemangiopericytoma
  • adult rhabdomyosarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • uterine leiomyosarcoma
  • Sarcoma

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