Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial (iPocc)

September 13, 2023 updated by: Gynecologic Oncology Trial & Investigation Consortium

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

655

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • High West
      • Hong Kong, High West, Hong Kong, 102
        • Queen Mary Hospital
  • Japan
      • Fukuoka, Japan, 810-8563
        • NHO Kyusyu Medical center
      • Hiroshima, Japan, 730-0051
        • JA Hiroshima General Hospital
      • Kagoshima, Japan, 892-8580
        • Kagoshima City Hospital
      • Kyoto, Japan, 602-0841
        • University Hospital, Kyoto Prefectural University of Medicine
      • Nagasaki, Japan, 850-0003
        • Saiseikai Nagasaki Hospital
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
      • Niigata, Japan, 951-8133
        • Niigata Cancer Center Hospital
      • Osaka, Japan, 537-8511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
      • Tottori, Japan, 680-0873
        • Tottori Municipal Hospital
    • Aichi
      • Chikusa, Aichi, Japan, 464-0021
        • Aichi Cancer Center Hospital
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 036-8203
        • Hirosaki University School of Medicine & Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8567
        • The Jikei University School of Medicine, Kashiwa Hospital
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0245
        • NHO Shikoku Cancer Center
      • Toon-shi, Ehime, Japan, 791-0204
        • Ehime University Hospital
    • Fukui
      • Yoshida, Fukui, Japan, 910-1104
        • University of Fukui Hospital
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hospital
      • Ōta, Gunma, Japan, 373-8550
        • Gunma Prefectural Cancer Center
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0023
        • NHO Kure Medical Center and Chugoku Cancer Center
      • Miyoshi, Hiroshima, Japan, 728-8502
        • Miyoshi Central Hospital
    • Hyogo
      • Akashi, Hyogo, Japan, 673-0021
        • Hyogo Cancer Center
      • Himeji, Hyogo, Japan, 670-0063
        • Japanese Red Cross Society Himeji Hospital
      • Kobe, Hyogo, Japan, 650-0047
        • Kobe City Medical Center General Hospital
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Hyogo Medical College Hospital
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • Tsukuba University Hospital
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Iwate Medical University Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1143
        • Tokai University Hospital
      • Kawasaki-shi, Kanagawa, Japan, 211-8533
        • Nippon Medical University Musasi Kosugi Hospital
      • Yokohama, Kanagawa, Japan, 240-8555
        • Yokohama Municipal Citizen's Hospital
    • Mie
      • Tsu, Mie, Japan, 514-8507
        • Mie University Hospital
      • Yokkaichi, Mie, Japan, 510-8561
        • Mie Prefectural General Medical Center
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0872
        • Tohoku University Hospital
    • Nagano
      • Matsumoto, Nagano, Japan, 390-0802
        • Shinshu University Hospital
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Nara Medical University Hospital
    • Okinawa
      • Uruma, Okinawa, Japan, 904-2293
        • Okinawa prefectural Chubu Hospital
    • Osaka
      • Kaizuka, Osaka, Japan, 597-0015
        • Kaizuka City Hospital
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Hospital
      • Takatsuki, Osaka, Japan, 569-0801
        • Osaka Medical College Hospital
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Kawagoe, Saitama, Japan, 350-8550
        • Saitama Medical University Saitama Medical Center
    • Shizuoka
      • Nagaizumi, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
      • Utsunomiya, Tochigi, Japan, 320-0834
        • Tochigi Cancer Center
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-0033
        • Juntendo University Hospital
      • Bunkyō-Ku, Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital
      • Komae, Tokyo, Japan, 201-8601
        • The Jikei University Daisan Hospital
      • Koto-Ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
      • Minato-Ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital
      • Shinagawa-Ku, Tokyo, Japan, 142-8666
        • Showa University Hospital
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Shinjuku-Ku, Tokyo, Japan, 162-0054
        • Tokyo Women's Medical University Medical Center East
    • Tottori
      • Yonago, Tottori, Japan, 683-8504
        • Tottori University
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital
  • Korea, Republic of
    • Gongneung-Dong
      • Seoul, Gongneung-Dong, Korea, Republic of, 139-706
        • Korea Cancer Center Hospital
    • Seoul
      • Dogok, Seoul, Korea, Republic of, 250
        • Gangnam Severance Hospital in Korea
      • P'ungnap-tong, Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Yangcheon, Seoul, Korea, Republic of, 1071
        • Ewha womans university medical center
    • Shinchon
      • Seoul, Shinchon, Korea, Republic of, 03722
        • Shinchon Severance Hospital
  • New Zealand
      • Christchurch, New Zealand
        • University of Otago - Christchurch/Christchurch Women's Hospital
  • Singapore
      • Bukit Timah, Singapore, 229899
        • KK Women's and Children's Hospital
      • Kent Ridge, Singapore, 119074
        • National University Hospital of Singapore
  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, Pa 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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(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.
Other Names:
  • Paclitaxel(Sawai),(NK), Paraplatin(BMS), Carboplatin(SANDOZ)
Experimental: 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(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 Names:
  • Paclitaxel(Sawai),(NK), Paraplatin(BMS), Carboplatin(SANDOZ)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome Measure
Time Frame
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
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)
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
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
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
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
Time Frame: After the last cycle of the protocol teatment
After the last cycle of the protocol teatment
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
baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment
Cost-utility analysis
Time Frame: baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment
baseline, after 3 cycles, 6 cycles, 36 week, 60 weeks and 84 weeks from the start of protocol treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Trial & Investigation Consortium

Collaborators

Japanese Gynecologic Oncology Group

Investigators

  • Study Chair: Keiichi Fujiwara, MD, PhD, Saitama Medical University International Medical Center Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

January 5, 2012

First Posted (Estimated)

January 10, 2012

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOTIC-001/JGOG3019
  • UMIN000003670 (Other Grant/Funding Number: University Hospital Medical Information Network = UMIN)
  • jRCTs031180141 (Other Grant/Funding Number: jRCT（Japan Registry of Clinical Trials）)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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