- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00011986
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma
Studieoversigt
Status
Detaljeret beskrivelse
OBJECTIVES:
Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine, doxorubicin HCl liposome, or topotecan, in terms of overall and progression-free survival, in patients with stage III or IV ovarian epithelial or serous primary peritoneal carcinoma.
Determine the response rate in patients with measurable disease treated with these regimens.
Compare the toxic effects of these regimens in these patients. Compare the complications in patients treated with these regimens. Determine the dose-intensity and cumulative dose delivery for these regimens in these patients.
OUTLINE:
This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery: Stratum A: Optimal (microscopic or macroscopic) residual disease without plans for surgery Stratum B: Suboptimal residual disease without plans for surgery Stratum C: Suboptimal residual disease with plans for surgeryPatients are randomized to 1 of 5 treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues as in arm I. Arm III: Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I. Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Arm V: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy. Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy. Patients are followed every 3 months for 2 years and then every 6 months.
PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be accrued for this study within 3.5-5 years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically confirmed stage III or IV ovarian epithelial or serous primaryperitoneal carcinoma
The following are ineligible:
- Germ cell tumors
- Sex cord-stromal tumors
- Carcinosarcomas
- Mixed Mullerian tumors or carcinosarcomas
- Metastatic carcinomas from other sites to theovary
- Low malignant potential tumors, including micropapillary serouscarcinomas
- Mucinous primary peritoneal carcinoma
- Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy
- Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
Prior breast cancer allowed provided the following are true:
- Disease-free for more than 5 years
- No prior cytotoxic chemotherapy for breast cancer
Prior or concurrent primary endometrial cancer allowed if the following conditions are met:
- Stage no greater than IB
- Less than 3 mm invasion without vascular or lymphatic invasion
- No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
- 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)
- AST no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- No acute hepatitis
- Creatinine no greater than 1.5 times ULN
- No unstable angina
- No myocardial infarction within the past 6 months
- No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) unless stable for the past 6 months
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No greater than grade 1 sensory or motor neuropathy
- No active infection that requires antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No severe or ongoing gastrointestinal bleeding that requires blood product support
- See Disease Characteristics
Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true:
- More than 3 years since prior therapy
- No evidence of recurrent disease
- No prior radiotherapy to any portion of the abdominal cavity or pelvis
Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true:
- More than 3 years since prior therapy
- No evidence of recurrent disease
- See Disease Characteristics
- No more than 12 weeks since prior surgical resection
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Arm I
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
|
Givet IV
Givet IV
Andre navne:
|
Eksperimentel: Arm II
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
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Givet IV
Givet IV
Andre navne:
Givet IV
Andre navne:
|
Eksperimentel: Arm III
Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I.
|
Givet IV
Givet IV
Andre navne:
Andre navne:
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Eksperimentel: Arm IV
Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses.
Patients then receive 4 courses of arm I chemotherapy.
|
Givet IV
Givet IV
Andre navne:
Givet IV
Andre navne:
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Eksperimentel: Arm V
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses.
Patients then receive 4 courses of arm I chemotherapy.
Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.
|
Givet IV
Givet IV
Andre navne:
Givet IV
Andre navne:
Gennemgå operation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall Survival
Tidsramme: Up to 9 years
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Proportion of participants whose overall survival exceeded 5 years.
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Up to 9 years
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Progression-free Survival
Tidsramme: From the date of enrollment to first progression or death or last contact, if alive and progression free.
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Median duration in months of progression free survival.
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From the date of enrollment to first progression or death or last contact, if alive and progression free.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0
Tidsramme: Up to 9 years
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Up to 9 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael Bookman, Gynecologic Oncology Group
Publikationer og nyttige links
Generelle publikationer
- Rose PG, Java JJ, Salani R, Geller MA, Secord AA, Tewari KS, Bender DP, Mutch DG, Friedlander ML, Van Le L, Method MW, Hamilton CA, Lee RB, Wenham RM, Guntupalli SR, Markman M, Muggia FM, Armstrong DK, Bookman MA, Burger RA, Copeland LJ. Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma. Obstet Gynecol. 2019 Feb;133(2):245-254. doi: 10.1097/AOG.0000000000003086. Erratum In: Obstet Gynecol. 2019 Apr;133(4):830.
- Han MK, Tayob N, Murray S, Dransfield MT, Washko G, Scanlon PD, Criner GJ, Casaburi R, Connett J, Lazarus SC, Albert R, Woodruff P, Martinez FJ. Predictors of chronic obstructive pulmonary disease exacerbation reduction in response to daily azithromycin therapy. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1503-8. doi: 10.1164/rccm.201402-0207OC.
- Nickles Fader A, Java J, Ueda S, Bristow RE, Armstrong DK, Bookman MA, Gershenson DM; Gynecologic Oncology Group (GOG)*. Survival in women with grade 1 serous ovarian carcinoma. Obstet Gynecol. 2013 Aug;122(2 Pt 1):225-232. doi: 10.1097/AOG.0b013e31829ce7ec.
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
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Karcinom
- Ovariale neoplasmer
- Karcinom, ovarieepitel
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antibiotika, antineoplastisk
- Topoisomerase I-hæmmere
- Gemcitabin
- Carboplatin
- Paclitaxel
- Doxorubicin
- Liposomal doxorubicin
- Topotecan
Andre undersøgelses-id-numre
- GOG-0182 (Anden identifikator: CTEP)
- U10CA027469 (U.S. NIH-bevilling/kontrakt)
- NCI-2012-02376 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- SWOG-G0182
- CDR0000068467
- ISRCTN41636183
- MRC-ICON5
- ECOG-G0182
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