Clinical trial · Interventional
Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel(intravenous) + Carboplatin(intraperitoneal) | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
| Paclitaxel(intravenous) + Carboplatin(intravenous) | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard treatment: dd-TCiv therapy
- description
- Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IV infusion once every 3 weeks
- interventionNames
- Drug: Paclitaxel(intravenous) + Carboplatin(intravenous)
- type
- EXPERIMENTAL
- label
- Study treatment: dd-TCip therapy
- description
- Paclitaxel administered by IV infusion weekly plus concurrent carboplatin administered by IP injection once every 3 weeks
- interventionNames
- Drug: Paclitaxel(intravenous) + Carboplatin(intraperitoneal)
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDBristow 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 11870167
- BACKGROUNDNeijt 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 10963636
- BACKGROUNDPiccart 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 10793106
- BACKGROUNDOzols 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 12860964
- BACKGROUNDKatsumata 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 19767092