Clinical trial · Observational
Chemotherapy Toxicity On Quality of Life in Older Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
NCT01366183CI-TRIAL-00054181unknownClinicalTrials.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 trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA Fallopian Tube Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IB Fallopian Tube Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IC Fallopian Tube Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIA Fallopian Tube Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIB Fallopian Tube Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIC Fallopian Tube Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIIA Fallopian Tube Cancer AJCC v7 | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Fallopian Tube Cancer AJCC v7 | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Fallopian Tube Cancer AJCC v7 | Malignant Fallopian Tube Neoplasm |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment of Therapy Complications | Procedure | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pharmacological Study | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (quality of life questionnaire)
- description
- Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician. Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies. Patients' quality of life is assessed by the FACT-O, the FACT-Ntx subscale, the IADL, and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed.
- interventionNames
- Procedure: Assessment of Therapy Complications
- Drug: Carboplatin
- Biological: Filgrastim
- Drug: Paclitaxel
- Other: Pharmacological Study
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Tolerance to study treatment, defined as completing four cycles of study treatment, without dose reductions or treatment delays of over seven days
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible patients must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the ovary, peritoneum, or fallopian tube either by surgery, biopsy, fine-needle aspiration (FNA), paracentesis, or thoracentesis; a diagnosis of a mucinous cancer must be made by biopsy only * International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, and IV are eligible * Patients must have received no previous treatment for this malignancy other than surgery * Patients must be entered within eight weeks of confirmation of disease diagnosis by surgery, biopsy, FNA, paracentesis or thoracentesis if there is no primary surgery, and within twelve weeks of primary or staging surgery if patient received primary surgery * Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl * Platelets greater than or equal to 100,000/mcl * Bilirubin less than or equal upper limit of normal (ULN) * Creatinine less than or equal to 1.5 x ULN * Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, 2 or 3 * Effective XX/XX/2014, only patients 75 years of age or older are eligible for enrollment; (04/23/2012) (08/12/2013) * Patients must have recovered from the effects of recent surgery * Patients must be free of active infection requiring antibiotics * Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) * Patient and physician agree that they plan to conduct treatment according to Regimen 3 * Patient can read and understand sufficient English to be able to respond to questions posed by the study instruments Exclusion Criteria: * Patients who have received previous treatment for this malignancy other than surgery * Patients with other invasive malignancies whose previous cancer treatment contraindicates this protocol therapy * ?Borderline tumors? (tumors of low malignant potential) by surgery or biopsy are excluded * Patients with medical conditions that in the opinion of the investigator render treatment on this protocol unsafe should be excluded
References
Publications (0)
Data not yet available
No reference posted for this study.