Clinical trial · Interventional
Cisplatin and Paclitaxel in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day 1 Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
NCT00814086CI-TRIAL-00016498completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This phase I trial is studying the side effects and best dose of cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Endometrial Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Complication | — | UNRESOLVED | — |
| Malignant Ovarian Mixed Epithelial Tumor | — | UNRESOLVED | — |
| Neurotoxicity Syndrome | — | UNRESOLVED | — |
| Ovarian Brenner Tumor | Ovarian Brenner Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Clear Cell Cystadenocarcinoma | Ovarian Clear Cell Cystadenocarcinoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (paclitaxel, cisplatin)
- description
- Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Paclitaxel
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks
- timeFrame
- 12 weeks
Secondary outcomes (3)
- measure
- Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
* Stage IIB, IIC, III, or IV disease
* Optimal or suboptimal residual disease after debulking surgery within the past 12 weeks
* Appropriate tissue for histologic evaluation available
* The following histologic epithelial cell types are eligible:
* Serous adenocarcinoma
* Endometrioid adenocarcinoma
* Mucinous adenocarcinoma
* Undifferentiated carcinoma
* Clear cell adenocarcinoma
* Mixed epithelial carcinoma
* Transitional cell carcinoma
* Malignant Brenner tumor
* Adenocarcinoma not otherwise specified
* Carcinosarcoma
* No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
* No synchronous primary endometrial cancer or a history of primary endometrial cancer unless all of the following conditions are met:
* Stage ≤ IB disease
* No more than superficial myometrial invasion, without vascular or lymphatic invasion
* No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion
* GOG performance status 0-2
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* SGOT ≤ 2.5 times ULN
* Audiograms required after study chemotherapy courses 3 and 6 for patients with hearing loss, or who are experiencing tinnitus during study therapy
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception
* None of the following:
* Septicemia
* Severe infection requiring parenteral antibiotics
* Malnutrition requiring parenteral hyperalimentation
* Acute hepatitis
* Any other major medical conditions expected to interfere with completion of protocol therapy
* No active bleeding
* No circumstances that would prohibit completion of study therapy or required follow-up
* No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E)
* No other invasive malignancies, except for nonmelanoma skin cancer or other specific malignancies within the past 5 years, or whose previous cancer treatment contraindicates this protocol therapy
* No unstable angina or myocardial infarction within the past 6 months
* Abnormal cardiac conduction (e.g., bundle branch block or heart block) that has been stable for the past 6 months allowed
* No prior targeted therapy for the management of ovarian epithelial or primary peritoneal cavity cancer including, but not limited to, the following:
* Vaccines
* Antibodies
* Tyrosine kinase inhibitors
* No prior chemotherapy
* No prior radiotherapy
* No prior hormonal therapy for the management of epithelial ovarian or primary peritoneal cavity cancerReferences
Publications (0)
Data not yet available
No reference posted for this study.