Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
NCT ID: NCT01506856
Last Updated: 2023-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
655 participants
INTERVENTIONAL
2010-05-31
2021-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Phase A: To confirm the feasibility of paclitaxel administered by intravenous (IV) infusion weekly plus concurrent carboplatin administered by intraperitoneal (IP) injection once every 3 weeks (dd-TCip therapy).
Phase B: To compare the efficacy and safety of the following two treatment regimens as first-line chemotherapy in women with epithelial ovarian, Fallopian tube or primary peritoneal cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer
NCT00919984
Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
NCT00003644
Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma
NCT00226915
Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT00003560
Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer
NCT00170664
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
RegimenI(Standard treatment: dd-TCiv therapy): Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks
RegimenII(Study treatment: dd-TCip therapy): Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks
The 3-week period (21 days) is 1 cycle. Protocol treatment basically comprises 6 cycles. IDS is allowed to be performed after 3, 4 or 5 cycles of the protocol treatment. In such cases, the protocol treatment must be restarted within 8 weeks after IDS. If IDS is performed, patients can receive up to 3 additional cycles of the protocol treatment after IDS. If interval debulking surgery (IDS) is performed after 3, 4 or 5 cycles, the patients can receive up to 3 additional cycles of the protocol treatment. A total of 6 to 8 cycles will be repeated.
The analysis of efficacy will be performed on all randomized subjects in accordance with the intention-to-treat (ITT) principle. In order to assess the robustness of the results, the same analyses will be done using all randomized subjects who satisfy the eligibility criteria. The analysis of safety will be performed on all subjects who have received at least one dose of study treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard treatment: dd-TCiv therapy
Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks
Paclitaxel(intravenous) + Carboplatin(intravenous)
Paclitaxel(intravenous) + Carboplatin(intravenous) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IV infusion, Day1 A total of 6 to 8 cycles will be repeated.
Study treatment: dd-TCip therapy
Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks
Paclitaxel(intravenous) + Carboplatin(intraperitoneal)
Paclitaxel(intravenous) + Carboplatin(intraperitoneal) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IP injection, Day1 A total of 6 to 8 cycles will be repeated.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Paclitaxel(intravenous) + Carboplatin(intravenous)
Paclitaxel(intravenous) + Carboplatin(intravenous) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IV infusion, Day1 A total of 6 to 8 cycles will be repeated.
Paclitaxel(intravenous) + Carboplatin(intraperitoneal)
Paclitaxel(intravenous) + Carboplatin(intraperitoneal) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IP injection, Day1 A total of 6 to 8 cycles will be repeated.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients scheduled to undergo laparotomy
\*Both optimal and suboptimal patients will be eligible for the study (Suboptimal patients, as well as those who undergo only exploratory laparotomy, are eligible.)
3. ECOG Performance Status: 0-2
4. Patients who provide consent for placement of the IP port system, if randomized to Regimen II (Study treatment: dd-TCip therapy)
5. Patients expected to receive the first protocol treatment within 8 weeks after the comprehensive staging surgery
6. Lab data and clinical examination: Data within 28 days before the scheduled date of surgery
* Neutrophil count ≧ 1,500 /mm3
* Platelet count ≧ 100,000 /mm3
* AST (GOT) ≦ 100 IU/L
* ALT (GPT) ≦ 100 IU/L
* Total bilirubin \< 1.5 mg/dL
* Serum Creatinine \< 1.5 mg/dL
* Electrocardiogram (ECG): Patients with normal ECG, Asymptomatic patients with abnormal ECGs not requiring medical intervention
* Neuropathy(Both motor and sensory) ≦ Grade1 (CTCAE Version 4.0)
7. Patients expected to survive longer than 3 months from the start date of the protocol treatment
8. Patients aged 20 years and older at the time of tentative registration (with no upper age limit)
9. Patients who provide written informed consent for participation in this trial
Exclusion Criteria
2. Patients who have received previous chemotherapy or radiation therapy to treat the current disease
3. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study)
4. Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder
5. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
6. Patients with a pleural effusion requiring continuous drainage
7. Patients with an active infection requiring antibiotics
8. Patients who are pregnant, nursing or of child-bearing potential
9. Patients with evidence upon physical examination of brain tumor and any brain metastases
10. Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason
11. Patients with any signs/symptoms of interstitial pneumonia
20 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Japanese Gynecologic Oncology Group
OTHER
Gynecologic Oncology Trial & Investigation Consortium
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Keiichi Fujiwara, MD, PhD
Role: STUDY_CHAIR
Saitama Medical University International Medical Center Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Queen Mary Hospital
Hong Kong, High West, Hong Kong
Aichi Cancer Center Hospital
Chikusa, Aichi-ken, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, Japan
The Jikei University School of Medicine, Kashiwa Hospital
Kashiwa, Chiba, Japan
NHO Shikoku Cancer Center
Matsuyama, Ehime, Japan
Ehime University Hospital
Toon-shi, Ehime, Japan
University of Fukui Hospital
Yoshida, Fukui, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Gunma Prefectural Cancer Center
Ōta, Gunma, Japan
NHO Kure Medical Center And Chugoku Cancer Center
Kure, Hiroshima, Japan
Miyoshi Central Hospital
Miyoshi, Hiroshima, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Japanese Red Cross Society Himeji Hospital
Himeji, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Hyogo Medical College Hospital
Nishinomiya, Hyōgo, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Nippon Medical University Musasi Kosugi Hospital
Kawasaki-shi, Kanagawa, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Mie Prefectural General Medical Center
Yokkaichi, Mie-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
Nara Medical Univeｒsity Hospital
Kashihara, Nara, Japan
Okinawa Prefectural Chubu Hospital
Uruma, Okinawa, Japan
Kaizuka City Hospital
Kaizuka, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Saitama Medical University Saitama Medical Center
Kawagoe, Saitama, Japan
Shizuoka Cancer Center
Nakatogari, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
Juntendo University Hospital
Bunkyo, Tokyo, Japan
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
The Jikei University Daisan Hospital
Komae, Tokyo, Japan
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, Japan
The Jikei University Hospital
Minato-Ku, Tokyo, Japan
Showa University Hospital
Shinagawa-Ku, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Tokyo Women's Medical University Medical Center East
Shinjuku-Ku, Tokyo, Japan
Tottori University
Yonago, Tottori, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
NHO Kyusyu Medical center
Fukuoka, , Japan
JA Hiroshima General Hospital
Hiroshima, , Japan
Kagoshima City Hospital
Kagoshima, , Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, , Japan
Saiseikai Nagasaki Hospital
Nagasaki, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, , Japan
Tottori Municipal Hospital
Tottori, , Japan
University of Otago - Christchurch/Christchurch Women's Hospital
Christchurch, , New Zealand
KK Women's and Children's Hospital
Bukit Timah, , Singapore
National University Hospital of Singapore
Kent Ridge, , Singapore
Korea Cancer Center Hospital
Seoul, Gongneung-Dong, South Korea
Gangnam Severance Hospital in Korea
Dogok, Seoul, South Korea
Asan Medical Center
P’ungnap-tong, Seoul, South Korea
Ewha Womans University Medical Center
Yangcheon, Seoul, South Korea
Shinchon Severance Hospital
Seoul, Shinchon, South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bristow RE, Tomacruz RS, Armstrong DK, Trimble EL, Montz FJ. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis. J Clin Oncol. 2002 Mar 1;20(5):1248-59. doi: 10.1200/JCO.2002.20.5.1248.
Neijt JP, Engelholm SA, Tuxen MK, Sorensen PG, Hansen M, Sessa C, de Swart CA, Hirsch FR, Lund B, van Houwelingen HC. Exploratory phase III study of paclitaxel and cisplatin versus paclitaxel and carboplatin in advanced ovarian cancer. J Clin Oncol. 2000 Sep;18(17):3084-92. doi: 10.1200/JCO.2000.18.17.3084.
Piccart MJ, Bertelsen K, James K, Cassidy J, Mangioni C, Simonsen E, Stuart G, Kaye S, Vergote I, Blom R, Grimshaw R, Atkinson RJ, Swenerton KD, Trope C, Nardi M, Kaern J, Tumolo S, Timmers P, Roy JA, Lhoas F, Lindvall B, Bacon M, Birt A, Andersen JE, Zee B, Paul J, Baron B, Pecorelli S. Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst. 2000 May 3;92(9):699-708. doi: 10.1093/jnci/92.9.699.
Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. doi: 10.1200/JCO.2003.02.153. Epub 2003 Jul 14.
Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K; Japanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1331-8. doi: 10.1016/S0140-6736(09)61157-0. Epub 2009 Sep 18.
Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med. 1996 Dec 26;335(26):1950-5. doi: 10.1056/NEJM199612263352603.
Markman M, Bundy BN, Alberts DS, Fowler JM, Clark-Pearson DL, Carson LF, Wadler S, Sickel J. Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group. J Clin Oncol. 2001 Feb 15;19(4):1001-7. doi: 10.1200/JCO.2001.19.4.1001.
Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
Miyagi Y, Fujiwara K, Kigawa J, Itamochi H, Nagao S, Aotani E, Terakawa N, Kohno I; Sankai Gynecology Study Group (SGSG). Intraperitoneal carboplatin infusion may be a pharmacologically more reasonable route than intravenous administration as a systemic chemotherapy. A comparative pharmacokinetic analysis of platinum using a new mathematical model after intraperitoneal vs. intravenous infusion of carboplatin--a Sankai Gynecology Study Group (SGSG) study. Gynecol Oncol. 2005 Dec;99(3):591-6. doi: 10.1016/j.ygyno.2005.06.055. Epub 2005 Aug 10.
Fujiwara K, Armstrong D, Morgan M, Markman M. Principles and practice of intraperitoneal chemotherapy for ovarian cancer. Int J Gynecol Cancer. 2007 Jan-Feb;17(1):1-20. doi: 10.1111/j.1525-1438.2007.00809.x.
Demets DL. Futility approaches to interim monitoring by data monitoring committees. Clin Trials. 2006;3(6):522-9. doi: 10.1177/1740774506073115.
Huang HQ, Brady MF, Cella D, Fleming G. Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study. Int J Gynecol Cancer. 2007 Mar-Apr;17(2):387-93. doi: 10.1111/j.1525-1438.2007.00794.x.
Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, Siddik ZH, Judson IR, Gore ME, Wiltshaw E. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol. 1989 Nov;7(11):1748-56. doi: 10.1200/JCO.1989.7.11.1748.
Related Links
Access external resources that provide additional context or updates about the study.
Japanese Gynecologic Oncology Group
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UMIN000003670
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
jRCTs031180141
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GOTIC-001/JGOG3019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.