- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00039442
Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of capecitabine in patients with persistent or recurrent non-squamous cell carcinoma of the cervix who have failed higher priority treatment protocols.
II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine whether the mRNA tumor expression levels of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), and thymidine phosphorylase (TP) at baseline are potential predictors of clinical outcomes (response and survival) in patients treated with this drug.
IV. Determine whether the serum level of TP is a potential prognostic indicator of clinical outcomes (response and survival) in patients treated with this drug.
V. Determine whether the TS promoter polymorphism in peripheral blood is a potential prognostic indicator of clinical outcomes (response and survival) in patients treated with this drug.
VI. Determine the associations among the various measures of TS, DPD, and TP and clinical outcomes (response and survival) in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Arizona
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Phoenix, Arizona, Forente stater, 85012
- Gynecologic Oncology Group of Arizona
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Histologically confirmed primary non-squamous cell carcinoma (non-SCC) of the cervix
- Persistent or recurrent disease
Eligible subtypes include:
- Adenocarcinoma
- Adenosquamous cell carcinoma
- Undifferentiated carcinoma
- Documented disease progression
At least 1 unidimensionally measurable target lesion outside prior irradiation field
- At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, and MRI)
- At least 10 mm by spiral CT scan
Received 1 prior systemic chemotherapy regimen for advanced, metastatic, or recurrent non-SCC of the cervix
- Radiosensitizing chemotherapy administered in combination with primary radiotherapy is not counted as a systemic chemotherapy regimen
- Tissue blocks from initial diagnosis, metastasis, or recurrence available for submission to the GOG tissue bank
- Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol (if one exists), defined as any Temporarily closed GOG phase III protocol for the same patient population
- Performance status - GOG 0-2
- 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 no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Creatinine clearance at least 50 mL/min
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No Temporarily closed infection requiring antibiotics
- No grade 2 or greater sensory or motor neuropathy
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- At least 3 weeks since prior biological or immunological anticancer agents
- No more than 1 prior non-cytotoxic biologic therapy or cytostatic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) for recurrent or persistent non-SCC of the cervix
- See Disease Characteristics
- See Biologic therapy
- At least 3 weeks since prior chemotherapy and recovered
- No prior capecitabine
- No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
- At least 1 week since prior hormonal anticancer therapy
- Concurrent hormone replacement therapy allowed
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- Recovered from prior recent surgery
- At least 3 weeks since other prior anticancer therapy
- No prior cancer treatment that would preclude this study therapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Treatment
Patients receive oral capecitabine twice daily on days 1-14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Korrelative studier
Given orally
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Duration of objective response
Tidsramme: Up to 7 years
|
Up to 7 years
|
Frequency of adverse events, graded according to CTC version 2.0
Tidsramme: Up to 7 years
|
Up to 7 years
|
Frequency of objective response
Tidsramme: Up to 7 years
|
Up to 7 years
|
Severity of observed adverse events, graded according CTC version 2.0
Tidsramme: Up to 7 years
|
Up to 7 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Katherine Look, Gynecologic Oncology Group
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer, kjertel og epitel
- Sykdomsattributter
- Neoplasmer, komplekse og blandede
- Karsinom
- Tilbakefall
- Karsinom, Adenosquamous
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Capecitabin
Andre studie-ID-numre
- GOG-0128G (Annen identifikator: CTEP)
- U10CA027469 (U.S. NIH-stipend/kontrakt)
- NCI-2012-02469 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- CDR0000069384
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