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Trial record 4 of 11 for:    ANXA2

Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma

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ClinicalTrials.gov Identifier: NCT00085475
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : September 24, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE June 10, 2004
First Posted Date  ICMJE June 11, 2004
Last Update Posted Date September 24, 2012
Study Start Date  ICMJE April 2004
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Progression-free rate at 14 weeks
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00085475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • Response rate as assessed by RECIST criteria
  • Progression-free survival
  • Overall survival
  • Duration of response
  • Toxicity as assessed by CTC 3.0
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma
Official Title  ICMJE Phase II Study of Glivec (Imatinib) in Locally Advanced and/or Metastatic Soft Tissue Sarcomas Expressing the t(17;22)(q22;q13) Translocation Resulting in a COL1A1/PDGF-beta Fusion Protein i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)
Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.

Detailed Description

OBJECTIVES:

Primary

  • Determine the therapeutic activity of imatinib mesylate in patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.
  • Determine the progression-free rate at 14 weeks in patients treated with this drug.

Secondary

  • Determine objective response rate, progression-free survival, and overall survival in patients treated with this drug.
  • Determine the duration of response in patients treated with this drug.

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

Patients receive oral imatinib mesylate twice daily for at least 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 14 weeks receive imatinib mesylate for 12 additional weeks. Patients with a partial or complete response at 14 weeks undergo surgical resection if possible. If surgical resection of all remaining tumor is not possible OR if complete resection is not achieved (section margins positive), patients continue to receive imatinib mesylate in the absence of disease progression

Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE
  • Drug: imatinib mesylate
  • Procedure: conventional surgery
Study Arms  ICMJE Not Provided
Publications * Rutkowski P, Van Glabbeke M, Rankin CJ, Ruka W, Rubin BP, Debiec-Rychter M, Lazar A, Gelderblom H, Sciot R, Lopez-Terrada D, Hohenberger P, van Oosterom AT, Schuetze SM; European Organisation for Research and Treatment of Cancer Soft Tissue/Bone Sarcoma Group; Southwest Oncology Group. Imatinib mesylate in advanced dermatofibrosarcoma protuberans: pooled analysis of two phase II clinical trials. J Clin Oncol. 2010 Apr 1;28(10):1772-9. doi: 10.1200/JCO.2009.25.7899. Epub 2010 Mar 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2012)
17
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed dermatofibrosarcoma protuberans or giant cell fibroblastoma

    • Locally advanced or metastatic disease
  • Measurable disease
  • Not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
  • Documented progressive disease within the past 3 months

    • Previously irradiated lesions must show disease progression
  • Tumor expressing COL1A1/PDGF-beta by fluorescence in situ hybridization

    • Translocation t(17;22)(q22;q13)
  • No prior chemotherapy OR previously treated with 1, and only 1, line of combination chemotherapy with ifosfamide and doxorubicin OR 2 lines of single-agent therapy OR relapsed within 6 months after adjuvant chemotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 mg/dL* NOTE: *Transfusion allowed

Hepatic

  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
  • Bilirubin ≤ 1.5 times ULN
  • No uncontrolled hepatic disease

Renal

  • Creatinine ≤ 1.5 times ULN
  • No uncontrolled renal disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No uncontrolled diabetes
  • No active or uncontrolled infection
  • No concurrent severe or uncontrolled medical disease
  • No medical, psychological, familial, sociological, or geographical condition that would preclude study participation, compliance, or giving informed consent
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 28 days since prior biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent anticancer biologic agents

Chemotherapy

  • See Disease Characteristics
  • More than 28 days since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 6 months since prior radiotherapy
  • No concurrent radiotherapy

    • Concurrent palliative radiotherapy allowed provided radiotherapy will not be administered to a target lesion

Surgery

  • Not specified

Other

  • More than 28 days since prior investigational drugs
  • No concurrent therapeutic anticoagulation therapy with warfarin

    • Concurrent low-molecular weight heparin or mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
  • No other concurrent anticancer agents
  • No other concurrent investigational drugs
  • No other concurrent cytostatic agents
  • No other concurrent tyrosine kinase inhibitors
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Netherlands,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00085475
Other Study ID Numbers  ICMJE EORTC-62027
EORTC-62027
EUDRACT-2004-002538-20
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Allan T. van Oosterom, MD, PhD University Hospital, Gasthuisberg
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP