Clinical trial · Interventional
Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early closure based on audit by study investigators after 3 patients died on study.
Summary
Brief summary (as posted)
The main purpose of this trial is to look at how elderly women (70 years of age or older) with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or responds to standard carboplatin and paclitaxel chemotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Mixed Tumor, Mesodermal | Mixed Mesodermal (Mullerian) Tumor | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carboplatin/Paclitaxel
- description
- Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Therapy Completion Rate
- timeFrame
- 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
- description
- The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 70 or older * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is medically eligible and clinically appropriate to receive systemic chemotherapy * Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or uterus * Life expectancy greater than 6 months * Baseline laboratory values as described in protocol Exclusion Criteria: * Active infection requiring antibiotics at the time of starting chemotherapy * Prior pelvic radiotherapy \> 25% of bone marrow * Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs * Past history of bone marrow transplantation or stem cell support * Known history of central nervous system (CNS) metastasis * History of prior malignancy that required prior systemic therapy * Clinically significant cardiac disease * Uncontrolled diabetes mellitus * Any signs of intestinal obstruction * Participation in an investigational drug study within three weeks prior to study entry * History of psychiatric disability or other central nervous system disorder
References
Publications (1)
- RESULTMatulonis UA, Krag KJ, Krasner CN, Atkinson T, Horowitz NS, Lee H, Penson RT. Phase II prospective study of paclitaxel and carboplatin in older patients with newly diagnosed Mullerian tumors. Gynecol Oncol. 2009 Feb;112(2):394-9. doi: 10.1016/j.ygyno.2008.10.015. Epub 2008 Dec 5. PMID 19058838