Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
iPocc
A Randomized Phase II/III Trial of Intravenous (IV) Paclitaxel Weekly Plus IV Carboplatin Once Every 3 Weeks Versus IV Paclitaxel Weekly Plus Intraperitoneal (IP) Carboplatin Once Every 3 Weeks in Women With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
3 other identifiers
interventional
655
6 countries
62
Brief Summary
The purpose of this study is: 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2010
Longer than P75 for phase_2
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedSeptember 15, 2023
September 1, 2022
10.8 years
December 20, 2011
September 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival(PFS)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until 510 events are observed or until 3 years from the last patient is randomized to the study
Secondary Outcomes (6)
Overall survival (OS)
weekly during the protocl treatment, then every 3 months for the first 2 years, 6-month for the following 2 years, and once a year thereafter
Tumor response (only patients with evaluable disease)
every 2 cycles [after 2 cycles, after 4 cycles, after 6 cycles, (after 8 cycles)], the time of discontinuation of the protocol treatment and then at least annually during follow-up
Adverse events
weekly during the protocl treatment, then every 3 months for the first 2 years, 6-month for the following 2 years, and once a year thereafter
Treatment completion rate
After the last cycle of the protocol teatment
Quality of Life (QOL) assessments
baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment
- +1 more secondary outcomes
Study Arms (2)
Standard treatment: dd-TCiv therapy
ACTIVE COMPARATORPaclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks
Study treatment: dd-TCip therapy
EXPERIMENTALPaclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks
Interventions
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 : 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.
Eligibility Criteria
You may qualify if:
- Patients assumed to have a stageII-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis
- 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.)
- ECOG Performance Status: 0-2
- Patients who provide consent for placement of the IP port system, if randomized to Regimen II (Study treatment: dd-TCip therapy)
- Patients expected to receive the first protocol treatment within 8 weeks after the comprehensive staging surgery
- 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)
- +3 more criteria
You may not qualify if:
- Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer
- Patients who have received previous chemotherapy or radiation therapy to treat the current disease
- 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)
- 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
- Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
- Patients with a pleural effusion requiring continuous drainage
- Patients with an active infection requiring antibiotics
- Patients who are pregnant, nursing or of child-bearing potential
- Patients with evidence upon physical examination of brain tumor and any brain metastases
- Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason
- Patients with any signs/symptoms of interstitial pneumonia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
University of Pittsburgh
Pittsburgh, Pennsylvania, Pa 15213, United States
Queen Mary Hospital
Hong Kong, High West, 102, Hong Kong
Aichi Cancer Center Hospital
Chikusa, Aichi-ken, 464-0021, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, 036-8203, Japan
The Jikei University School of Medicine, Kashiwa Hospital
Kashiwa, Chiba, 277-8567, Japan
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0245, Japan
Ehime University Hospital
Toon-shi, Ehime, 791-0204, Japan
University of Fukui Hospital
Yoshida, Fukui, 910-1104, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Gunma Prefectural Cancer Center
ĹŚta, Gunma, 373-8550, Japan
NHO Kure Medical Center And Chugoku Cancer Center
Kure, Hiroshima, 737-0023, Japan
Miyoshi Central Hospital
Miyoshi, Hiroshima, 728-8502, Japan
Hyogo Cancer Center
Akashi, HyĹŤgo, 673-0021, Japan
Japanese Red Cross Society Himeji Hospital
Himeji, HyĹŤgo, 670-0063, Japan
Kobe City Medical Center General Hospital
Kobe, HyĹŤgo, 650-0047, Japan
Hyogo Medical College Hospital
Nishinomiya, HyĹŤgo, 663-8501, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Tokai University Hospital
Isehara, Kanagawa, 259-1143, Japan
Nippon Medical University Musasi Kosugi Hospital
Kawasaki-shi, Kanagawa, 211-8533, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, 240-8555, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Mie Prefectural General Medical Center
Yokkaichi, Mie-ken, 510-8561, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-0872, Japan
Shinshu University Hospital
Matsumoto, Nagano, 390-0802, Japan
Nara Medical Univeď˝’sity Hospital
Kashihara, Nara, 634-8522, Japan
Okinawa Prefectural Chubu Hospital
Uruma, Okinawa, 904-2293, Japan
Kaizuka City Hospital
Kaizuka, Osaka, 597-0015, Japan
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, 569-0801, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298, Japan
Saitama Medical University Saitama Medical Center
Kawagoe, Saitama, 350-8550, Japan
Shizuoka Cancer Center
Nakatogari, Shizuoka, 411-8777, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834, Japan
Juntendo University Hospital
Bunkyo, Tokyo, 113-0033, Japan
The University of Tokyo Hospital
BunkyĹŤ-Ku, Tokyo, 113-8655, Japan
The Jikei University Daisan Hospital
Komae, Tokyo, 201-8601, Japan
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo, 135-8550, Japan
The Jikei University Hospital
Minato-Ku, Tokyo, 105-8471, Japan
Showa University Hospital
Shinagawa-Ku, Tokyo, 142-8666, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582, Japan
Tokyo Women's Medical University Medical Center East
Shinjuku-Ku, Tokyo, 162-0054, Japan
Tottori University
Yonago, Tottori, 683-8504, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505, Japan
NHO Kyusyu Medical center
Fukuoka, 810-8563, Japan
JA Hiroshima General Hospital
Hiroshima, 730-0051, Japan
Kagoshima City Hospital
Kagoshima, 892-8580, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-0841, Japan
Saiseikai Nagasaki Hospital
Nagasaki, 850-0003, Japan
Niigata Cancer Center Hospital
Niigata, 951-8133, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, 537-8511, Japan
Tottori Municipal Hospital
Tottori, 680-0873, Japan
University of Otago - Christchurch/Christchurch Women's Hospital
Christchurch, New Zealand
KK Women's and Children's Hospital
Bukit Timah, 229899, Singapore
National University Hospital of Singapore
Kent Ridge, 119074, Singapore
Korea Cancer Center Hospital
Seoul, Gongneung-Dong, 139-706, South Korea
Gangnam Severance Hospital in Korea
Dogok, Seoul, 250, South Korea
Asan Medical Center
P’ungnap-tong, Seoul, 138-736, South Korea
Ewha Womans University Medical Center
Yangcheon, Seoul, 1071, South Korea
Shinchon Severance Hospital
Seoul, Shinchon, 03722, South Korea
Related Publications (13)
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.
PMID: 11870167BACKGROUNDNeijt 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.
PMID: 10963636BACKGROUNDPiccart 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.
PMID: 10793106BACKGROUNDOzols 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.
PMID: 12860964BACKGROUNDKatsumata 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.
PMID: 19767092BACKGROUNDAlberts 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.
PMID: 8960474BACKGROUNDMarkman 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.
PMID: 11181662BACKGROUNDArmstrong 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.
PMID: 16394300BACKGROUNDMiyagi 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.
PMID: 16095677BACKGROUNDFujiwara 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.
PMID: 17291226BACKGROUNDDemets DL. Futility approaches to interim monitoring by data monitoring committees. Clin Trials. 2006;3(6):522-9. doi: 10.1177/1740774506073115.
PMID: 17170036BACKGROUNDHuang 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.
PMID: 17362317BACKGROUNDCalvert 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.
PMID: 2681557BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Keiichi Fujiwara, MD, PhD
Saitama Medical University International Medical Center Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2011
First Posted
January 10, 2012
Study Start
May 1, 2010
Primary Completion
February 28, 2021
Study Completion
February 28, 2021
Last Updated
September 15, 2023
Record last verified: 2022-09