Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial (iPocc)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 20, 2014
Last verified: August 2014
  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: 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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 51 Study Locations
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: August 20, 2014
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:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Neoplasms by Histologic Type
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014