- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00354601
Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer
A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum
RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel together with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Determine the response rate in patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer treated with docetaxel and capecitabine.
Secondary
- Determine the time to progression in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life during treatment of these patients.
OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for ≥ 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, and then at completion of study treatment.
After completion of study treatment, patients are followed every 2-3 months.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27157-1096
- Wake Forest University Comprehensive Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
- Ovarian epithelial adenocarcinoma
- Fallopian tube cancer
- Peritoneal cavity cancer
- Recurrent or persistent disease after no more than 2 prior treatment regimens (1 regimen for primary disease and/or 1 regimen for recurrent disease)
Platinum-resistant disease, defined as 1 of the following:
- Treatment-free interval < 6 months after platinum-based therapy
- Disease progression during platinum-based therapy
- Measurable disease by physical exam, chest x-ray, CT scan, or MRI
- No brain metastases
PATIENT CHARACTERISTICS:
- Gynecologic Oncology Group performance status 0-2
- Life expectancy > 6 months
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8 g/dL
- Creatinine clearance ≥ 50 mL/min
- Bilirubin normal
AST or ALT and alkaline phosphatase (AP) meeting 1 of the following criteria:
- AST or ALT ≤ 5 times upper limit of normal (ULN) AND AP normal
- AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
- AST or ALT normal AND AP ≤ 5 times ULN
- No peripheral neuropathy > grade 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No other concurrent malignancy except for curatively treated nonmelanoma skin cancer
- No prior invasive malignancy < 5 years after curative therapy
- No serious uncontrolled medical or psychiatric illness that would preclude study participation or limit survival to < 6 months
- No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 or to fluoropyrimidine therapy or fluorouracil
- No inability to tolerate oral medication due to bowel obstruction, lack of physical integrity of the upper gastrointestinal tract, inability to swallow, or malabsorption syndrome
- No serious concurrent infections
No clinically significant cardiac disease not well controlled with medication, including any of the following:
- Congestive heart failure
- Symptomatic coronary artery disease
- Symptomatic cardiac arrhythmias
- Myocardial infarction within the past 12 months
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior docetaxel or capecitabine or other fluoropyrimidine therapy
- Recovered from prior therapy
- At least 2 weeks since prior major surgery
- At least 4 weeks since prior chemotherapy, hormone therapy, or radiotherapy
- No other concurrent chemotherapeutic agents, biological therapy, radiotherapy, or other investigational agents
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: Weekly Docetaxel and Capecitabine
|
oral capecitabine twice daily on days 1-21
docetaxel IV over 30 minutes on days 1, 8, and 15
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Tumor Response
Tidsramme: 8 weeks
|
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Progression
Tidsramme: Evaluated every 8 weeks during treatment
|
Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter
|
Evaluated every 8 weeks during treatment
|
|
Number of Participants With Grade 3 or Higher Toxicity
Tidsramme: Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
|
summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.
|
Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
|
|
Quality of Life
Tidsramme: Pre-entry, day 1, treatment end
|
comparison of treatment end to pre entry and day 1 of each treatment cycle.
|
Pre-entry, day 1, treatment end
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Peritoneale sygdomme
- Genitale neoplasmer, kvindelige
- Adnexale sygdomme
- Neoplasmer i fordøjelsessystemet
- Æggeledersygdomme
- Abdominale neoplasmer
- Æggelederneoplasmer
- Peritoneale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Docetaxel
- Capecitabin
Andre undersøgelses-id-numre
- CCCWFU-83203
- CCCWFU-BG05-536
- AVENTIS-CCCWFU-83203
- CDR0000489036
- ROCHE-CCCWFU-BG05-536
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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