Brief Title
Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
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
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.
Detailed Description
This is a randomized, multicenter international study. Patient are stratified according to
Residual tumor diameter([0cm(No residual)] vs. [0cm2 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 Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Progression-free survival(PFS)
Secondary Outcome
Overall survival (OS)
Condition
Epithelial Ovarian Cancer
Intervention
Paclitaxel(intravenous) + Carboplatin(intravenous)
Study Arms / Comparison Groups
Standard treatment: dd-TCiv therapy
Description: Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
654
Start Date
May 2010
Completion Date
May 2020
Primary Completion Date
November 2019
Eligibility 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
Gender
Female
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Keiichi Fujiwara, MD, PhD, ,
Location Countries
Hong Kong
Location Countries
Hong Kong
Administrative Informations
NCT ID
NCT01506856
Organization ID
GOTIC-001/JGOG3019
Secondary IDs
UMIN000003670
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Trial & Investigation Consortium
Collaborators
Japanese Gynecologic Oncology Group
Study Sponsor
Keiichi Fujiwara, MD, PhD, Study Chair, Saitama Medical University International Medical Center Comprehensive Cancer Center
Verification Date
February 2019