Clinical trial · Interventional
Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer
A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding withdrawn
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel together with carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity 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 |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cavity Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Weekly Docetaxel and Capecitabine
- description
- Weekly Docetaxel and Capecitabine
- interventionNames
- Drug: capecitabine
- Drug: docetaxel
Primary outcomes (1)
- measure
- Objective Tumor Response
- timeFrame
- 8 weeks
- description
- The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
Secondary outcomes (3)
- measure
- Time to Progression
- timeFrame
- Evaluated every 8 weeks during treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Ovarian epithelial adenocarcinoma * Fallopian tube cancer * Peritoneal cavity cancer * Recurrent or persistent disease after no more than 2 prior treatment regimens (1 regimen for primary disease and/or 1 regimen for recurrent disease) * Platinum-resistant disease, defined as 1 of the following: * Treatment-free interval \< 6 months after platinum-based therapy * Disease progression during platinum-based therapy * Measurable disease by physical exam, chest x-ray, CT scan, or MRI * No brain metastases PATIENT CHARACTERISTICS: * Gynecologic Oncology Group performance status 0-2 * Life expectancy \> 6 months * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8 g/dL * Creatinine clearance ≥ 50 mL/min * Bilirubin normal * AST or ALT and alkaline phosphatase (AP) meeting 1 of the following criteria: * AST or ALT ≤ 5 times upper limit of normal (ULN) AND AP normal * AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN * AST or ALT normal AND AP ≤ 5 times ULN * No peripheral neuropathy \> grade 2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * No other concurrent malignancy except for curatively treated nonmelanoma skin cancer * No prior invasive malignancy \< 5 years after curative therapy * No serious uncontrolled medical or psychiatric illness that would preclude study participation or limit survival to \< 6 months * No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 or to fluoropyrimidine therapy or fluorouracil * No inability to tolerate oral medication due to bowel obstruction, lack of physical integrity of the upper gastrointestinal tract, inability to swallow, or malabsorption syndrome * No serious concurrent infections * No clinically significant cardiac disease not well controlled with medication, including any of the following: * Congestive heart failure * Symptomatic coronary artery disease * Symptomatic cardiac arrhythmias * Myocardial infarction within the past 12 months PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior docetaxel or capecitabine or other fluoropyrimidine therapy * Recovered from prior therapy * At least 2 weeks since prior major surgery * At least 4 weeks since prior chemotherapy, hormone therapy, or radiotherapy * No other concurrent chemotherapeutic agents, biological therapy, radiotherapy, or other investigational agents
References
Publications (0)
Data not yet available