Clinical trial · Interventional
Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer
NCT00006812CI-TRIAL-00010000terminatedPhase 2ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have recurrent 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 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven recurrent ovarian epithelial or primary peritoneal cavity cancer * Measurable disease * At least 1 unidimensionally measurable lesion * Ascites and pleural effusions are not considered measurable disease * Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound * Treatment-free interval of 6-12 months after response to platinum therapy * Not eligible for higher priority GOG protocol PATIENT CHARACTERISTICS: Age: * Any age Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least lower limit of normal Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine clearance at least 50 mL/min Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No neuropathy (sensory and motor) greater than grade 1 * No other malignancy within the past 5 years except nonmelanoma skin cancer * No concurrent active infection requiring antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic or immunologic therapy * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: * See Disease Characteristics * If no prior therapy with paclitaxel, a second regimen including paclitaxel allowed * No prior capecitabine or fluorouracil * No prior chemotherapy for recurrent or persistent disease, including pretreatment with initial chemotherapy regimens * Recovered from prior chemotherapy Endocrine therapy: * At least 1 week since prior hormonal therapy directed at malignant tumor * Concurrent continuation of hormone replacement therapy allowed Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered * No prior radiotherapy to site(s) of measurable disease * No prior radiotherapy to more than 25% of bone marrow Surgery: * Recovered from prior surgery Other: * No prior cancer treatment that would preclude study therapy * No concurrent amifostine or other protective reagents
References
Publications (1)
- RESULTGarcia AA, Blessing JA, Lenz HJ, Darcy KM, Mannel RS, Miller DS, Husseinzadeh N; Gynecologic Oncology Group. Phase II clinical trial of capecitabine in ovarian carcinoma recurrent 6-12 months after completion of primary chemotherapy, with exploratory TS, DPD, and TP correlates: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Mar;96(3):810-7. doi: 10.1016/j.ygyno.2004.11.037. PMID 15721430