- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00041041
Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
A Phase II Evaluation Of Gleevec (Imatinib Mesylate) (IND #61135, NSC #716051) In The Treatment Of Persistent Or Recurrent Epithelial Ovarian Or Primary Peritoneal Carcinoma
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. To evaluate the cytostatic, anti-tumor activity of Gleevec (Imatinib Mesylate) through the probability of surviving progression-free for at least 6 months in patients with recurrent or persistent epithelial ovarian or primary peritoneal carcinoma receiving Gleevec.
II. To determine the frequency and severity of adverse effects of Gleevec in this cohort of patients as assessed by CTC.
SECONDARY OBJECTIVES:
I. To determine the distribution of the overall survival. II. To determine the distribution of progression-free survival. III. To estimate the clinical response rate (partial and complete response as defined under the RECIST criteria).
IV. To assess the effects of prognostic variables: initial performance status, platinum sensitivity, and mucinous (or clear cell) histology).
TERTIARY OBJECTIVES:
I. To determine the levels of expression of c-KIT and its ligand, stem cell factor (SCF) in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.
II. To determine the levels of expression of platelet derived growth factor receptor (PDGFR) and its ligand PDGF in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.
III. To determine the levels of expression of AKT2 and its activated form, phospho-AKT2, in archived, formalin fixed, paraffin embedded primary tumors collected prior to the initiation of first-line chemotherapy.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19103
- Gynecologic Oncology Group
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
- Recurrent or persistent disease
At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Tumors within a previously irradiated field considered nontarget lesions
At least one prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for primary disease required
- Initial treatment may include high-dose, consolidation, or extended therapy
- Initial treatment-free interval less than 12 months for patients who received only 1 prior platinum-based regimen
- Initial treatment-free interval of more than 12 months allowed provided disease progression has occurred within 12 months after retreatment with a second-line platinum-based regimen
- Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
- Performance status - GOG 0-2 (if patient has received one prior treatment regimen)
- Performance status - GOG 0-1 (if patient has received two prior treatment regimens)
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT/SGPT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Creatinine no greater than 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- No active infection requiring antibiotics
- No greater than grade 1 sensory and motor neuropathy
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No signs or symptoms of bowel dysfunction
- At least 3 weeks since prior immunologic therapy directed at the malignant tumor
- No concurrent biologic therapy or immunotherapy for the malignant tumor
- Recovered from prior chemotherapy
- No prior noncytotoxic chemotherapy for persistent or recurrent disease
- One additional cytotoxic regimen for persistent or recurrent disease allowed
- No concurrent chemotherapy for the malignant tumor
- At least 1 week since prior hormonal therapy directed at the malignant tumor
- No concurrent therapeutic corticosteroids
- No concurrent anticancer hormonal therapy
- Concurrent hormone replacement therapy allowed
- Recovered from prior radiotherapy
- No prior radiotherapy to more than 25% of marrow-bearing areas
- No concurrent anticancer radiotherapy
- Recovered from recent prior surgery
- At least 3 weeks since other prior therapies directed at the malignant tumor
- No prior imatinib mesylate
- No prior anticancer therapy that would preclude study participation
- No concurrent therapeutic anticoagulation with warfarin
- No other concurrent investigational drugs
- No concurrent amifostine or other protective reagents
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Korrelative undersøgelser
Givet PO
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Progressionsfri overlevelse
Tidsramme: Ved 6 måneder
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Ved 6 måneder
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Hyppighed og sværhedsgrad af bivirkninger vurderet af CTC
Tidsramme: Op til 7 år
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Op til 7 år
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Varighed af progressionsfri overlevelse
Tidsramme: Op til 7 år
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Op til 7 år
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Varigheden af den samlede overlevelse
Tidsramme: Op til 7 år
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Op til 7 år
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Hyppighed af klinisk respons (delvis og fuldstændig respons)
Tidsramme: Op til 7 år
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Op til 7 år
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Prognostic variables: initial performance status, age, platinum sensitivity, and mucinous (or clear cell) histology
Tidsramme: Baseline
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Baseline
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Sygdomsegenskaber
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Ovariale neoplasmer
- Tilbagevenden
- Karcinom, ovarieepitel
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Proteinkinasehæmmere
- Imatinib mesylat
Andre undersøgelses-id-numre
- NCI-2012-02473
- U10CA027469 (U.S. NIH-bevilling/kontrakt)
- GOG-0170E
- CDR0000069438 (Registry Identifier: PDQ (Physician Data Query))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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