Clinical trial · Interventional
Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
A Phase I Dose-Finding Study of Oxaliplatin (NSC #266046) Combined With Continuous Infusion Topotecan Hydrochloride as Chemotherapy for Patients With Previously Treated Ovarian Cancer
- 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with topotecan in treating patients who have previously treated ovarian epithelial, primary peritoneal, or fallopian tube 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 |
|---|---|---|---|
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer * Prior chemotherapy required * Measurable or evaluable disease * No symptomatic, untreated brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * At least 4 months Hematopoietic: * WBC greater than 3,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR * SGOT no greater than 2.5 times ULN (5 times ULN if liver metastases) Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 50 mL/min Cardiovascular: * No uncontrolled symptomatic congestive heart failure * No unstable angina pectoris * No uncontrolled cardiac arrhythmia Other: * No other active cancer * No prior allergy to platinum compounds * No prior allergic reactions to appropriate antiemetics (e.g., serotonin or antagonists) administered concurrently with study * No other uncontrolled concurrent illness (e.g., infection) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * No concurrent colony stimulating factors during topotecan administration Chemotherapy: * See Disease Characteristics * No prior high-dose chemotherapy requiring bone marrow or peripheral blood stem cell transplantation * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to whole pelvic field * At least 2 weeks since prior radiotherapy and recovered Surgery: * No unresolved sequelae resulting from prior surgery Other: * At least 4 weeks since other prior investigational drug * No other concurrent investigational agents * No other concurrent anticancer therapy
References
Publications (1)
- RESULTHochster H, Chen TT, Lu JM, Hills D, Sorich J, Escalon J, Ivy P, Liebes L, Muggia F. Tolerance and activity of oxaliplatin with protracted topotecan infusion in patients with previously treated ovarian cancer. A phase I study. Gynecol Oncol. 2008 Mar;108(3):500-4. doi: 10.1016/j.ygyno.2007.11.017. Epub 2008 Jan 11. PMID 18191187