Clinical trial · Interventional
Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer
A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma
- 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)
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Toxicity
- measure
- Response rates (complete and partial response)
- measure
- Relapse rates
- measure
- Event-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer * Stage III or IV disease * No borderline tumors * Measurable or evaluable disease * Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation * Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart) * In first relapse * Platinum-sensitive disease, defined as initial relapse \> 6 months after completion of a platinum-based regimen PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * Bilirubin normal * Meets 1 of the following criteria: * SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN * SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal Renal * Creatinine ≤ 2.0 mg/dL * Creatinine clearance \> 50 mL/min Cardiovascular * LVEF ≥ 50% * No poorly controlled arrhythmia * No unstable coronary artery disease or myocardial infarction within the past year Other * HIV negative * No pre-existing peripheral neuropathy \> grade 2 * No history of allergy to study drugs PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy and recovered Endocrine therapy * Not specified Radiotherapy * At least 3 weeks since prior radiotherapy and recovered Surgery * Recovered from recent prior surgery Other * No concurrent myelosuppressive therapy
References
Publications (0)
Data not yet available