Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial (iPocc)

This study is currently recruiting participants.
Verified June 2013 by Gynecologic Oncology Trial & Investigation Consortium
Sponsor:
Collaborator:
Japanese Gynecologic Oncology Group
Information provided by (Responsible Party):
Gynecologic Oncology Trial & Investigation Consortium
ClinicalTrials.gov Identifier:
NCT01506856
First received: December 20, 2011
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Drug: Paclitaxel(intravenous) + Carboplatin(intravenous)
Drug: Paclitaxel(intravenous) + Carboplatin(intraperitoneal)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Trial & Investigation Consortium:

Primary Outcome Measures:
  • Progression-free survival(PFS) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Tumor response (only patients with evaluable disease) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Treatment completion rate [ Time Frame: After the last cycle of the protocol teatment ] [ Designated as safety issue: No ]
  • Quality of Life (QOL) assessments [ Time Frame: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment ] [ Designated as safety issue: No ]
  • Cost-utility analysis [ Time Frame: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 685
Study Start Date: May 2010
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Regimen I (Standard treatment: dd−TCiv therapy)
Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks
Drug: 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.

Experimental: Regimen II (Study treatment: dd-TCip therapy)
Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks
Drug: 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.


Detailed Description:

This is a randomized, multicenter international study. Patient are stratified according to Residual tumor diameter([0cm(No residual)] vs. [0cm<residual<1cm] vs. [1cm<residual<2cm] vs. [>2 cm]), FIGO stage(StageII vs. III vs. IV) and institution. Patient randomized to one of the treatment arms described below.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients assumed to have a stageII−IV epithelial ovarian, fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis
  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:

  1. Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506856

Contacts
Contact: iPocc Trial Coordinating Center +81-3-5791-6419 iPocc@insti.kitasato-u.ac.jp

Locations
Japan
Aichi Cancer Center Hospital Recruiting
Kanokoden, Chikusa-ku, Nagoya-shi, Aichi, Japan, 464-0021
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
The Jikei University School of Medicine, Kashiwa Hospital Recruiting
Kashiwashita, Kashiwa-shi, Chiba, Japan, 277-8567
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
NHO Shikoku Cancer Center Recruiting
Kou160 Minamiumemotomachi, Matsuyama-shi, Ehime, Japan, 791-0245
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
University of Fukui Hospital Recruiting
Matsuokashimoaizuki, Yoshida-gun, Eiheiji-cho, Fukui, Japan, 910-1104
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
NHO Kyusyu Medical center Recruiting
Jigyohama, Fukuoka-shi Chuo-ku, Fukuoka, Japan, 810-8563
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Gunma University Hospital Recruiting
Showamachi, Maebashi-shi, Gunma, Japan, 371-8511
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Gunma Prefectural Cancer Center Recruiting
Takahayashinishicho, Ota-shi, Gunma, Japan, 373-8550
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
NHO Kure Medical Center And Chugoku Cancer Center Recruiting
Aoyamacho, Kure-shi, Hiroshima, Japan, 737-0023
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Miyoshi Central Hospital Recruiting
Higashisakeyamachi, Miyoshi-shi, Hiroshima, Japan, 728-8502
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
JA Hiroshima General Hospital Recruiting
Otemachi, Hiroshima-shi Naka-ku, Hiroshima, Japan, 730-0051
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Kobe City Medical Center General Hospital Recruiting
Minatojimaminamimachi, Kobe-shi Chuo-ku, Hyogo, Japan, 650-0047
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Hyogo Medical College Hospital Recruiting
Mukogawacho, Nishinomiya-shi, Hyogo, Japan, 663-8501
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Tsukuba University Hospital Recruiting
Amakubo, Tsukuba-shi, Ibaraki, Japan, 305-8576
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Iwate Medical University Hospital Recruiting
Uchimaru, Morioka-shi, Iwate, Japan, 020-8505
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Kagoshima City Hospital Recruiting
Kajiyacho, Kagoshima-shi, Kagoshima, Japan, 892-8580
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Yokohama Municipal Citizen's Hospital Recruiting
Okazawacho, Yokohama-shi Hodogaya-ku, Kanagawa, Japan, 240-8555
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Tokai University Hospital Recruiting
Shimokasuya, Isehara-shi, Kanagawa, Japan, 259-1143
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Mie University Hospital Recruiting
Edobashi, Tsu-shi, Mie, Japan, 514-8507
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Mie Prefectural General Medical Center Recruiting
Hinaga, Yokkaichi-shi, Mie, Japan, 510-8561
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Tohoku University Hospital Recruiting
Seiryocho, Sendai-shi Aoba-ku, Miyagi, Japan, 980-0872
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Shinshu University Hospital Recruiting
Asahi, Matsumoto-shi, Nagano, Japan, 390-0802
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Saiseikai Nagasaki Hospital Recruiting
Katafuchi, Nagasaki-shi, Nagasaki, Japan, 850-0003
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Nara Medical University Hospital Recruiting
Shijocho, Kashihara-shi, Nara, Japan, 634-8522
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Niigata University Medical & Dental Hospital Recruiting
Asahimachidori, Niigata-shi Chuo-ku, Niigata, Japan, 951-8520
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Niigata Cancer Center Hospital Recruiting
Kawagishicho, Niigata-shi Chuo-ku, Niigata, Japan, 951-8133
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Okinawa Prefectural Chubu Hospital Recruiting
Miyazato, Uruma-shi, Okinawa, Japan, 904-2293
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Osaka Medical College Hospital Recruiting
Daigakumachi, Takatsuki-shi, Osaka, Japan, 569-0801
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Kaizuka City Hospital Recruiting
Hori, Kaizuka-shi, Osaka, Japan, 597-0015
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Osaka Medical Center for Cancer and Cardiovascular Diseases Recruiting
Nakamichi, Osaka-shi Higashinari-ku, Osaka, Japan, 537-8511
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Osaka University Hospital Recruiting
Yamadaoka, Suita-shi, Osaka, Japan, 565-0871
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Saitama Medical University Saitama Medical Center Recruiting
Kamoda, Kawagoe-shi, Saitama, Japan, 350-8550
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Saitama Medical University International Medical Center Recruiting
Yamane, Hidaka-shi, Saitama, Japan, 350-1298
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Shizuoka Cancer Center Recruiting
Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan, 411-8777
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Jichi Medical University Hospital Recruiting
Yakushiji, Shimotsuke-shi, Tochigi, Japan, 329-0498
Contact: Eriko Aotani    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Tochigi Cancer Center Recruiting
Yonan, Utsunomiya-shi, Tochigi, Japan, 320-0834
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
The Cancer Institute Hospital Of JFCR Recruiting
Ariake, Koto-ku, Tokyo, Japan, 135-8550
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Showa University Hospital Recruiting
Hatanodai, Shinagawa-ku, Tokyo, Japan, 142-8666
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
The Jikei University Daisan Hospital Recruiting
Izumihoncho, Komae-shi, Tokyo, Japan, 201-8601
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Tokyo Women's Medical University Medical Center East Recruiting
Kawadacho, Shinjuku-ku, Tokyo, Japan, 162-0054
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
The Jikei University Hospital Recruiting
Nishishinbashi, Minato-ku, Tokyo, Japan, 105-8471
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Keio University Hospital Recruiting
Shinanomachi, Shinjuku-ku, Tokyo, Japan, 160-8582
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Tottori Municipal Hospital Recruiting
Matoba, Tottori-shi, Tottori, Japan, 680-0873
Contact: Eriko Aotani, RN, MSN, CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Tottori University Recruiting
Nishicho, Yonago-shi, Tottori, Japan, 683-8504
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Yamaguchi University Hospital Recruiting
Minamikogushi, Ube-shi, Yamaguchi, Japan, 755-8505
Contact: Eriko Aotani, RN,MSN,CCRP    +81-3-5791-6419    iPocc@insti.kitasato-u.ac.jp   
Sponsors and Collaborators
Gynecologic Oncology Trial & Investigation Consortium
Japanese Gynecologic Oncology Group
Investigators
Study Chair: Keiichi Fujiwara, MD, PhD Saitama Medical University International Medical Center Comprehensive Cancer Center
  More Information

Additional Information:
Publications:

Responsible Party: Gynecologic Oncology Trial & Investigation Consortium
ClinicalTrials.gov Identifier: NCT01506856     History of Changes
Other Study ID Numbers: GOTIC-001/JGOG3019, UMIN000003670
Study First Received: December 20, 2011
Last Updated: June 27, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Gynecologic Oncology Trial & Investigation Consortium:
Epithelial ovarian cancer
Fallopian tube cancer
peritoneal cancer
intraperitoneal therapy
Carboplatin
Paclitaxel

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014