Clinical trial · Interventional
Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan
- 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 gemcitabine and topotecan, 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 gemcitabine together with topotecan works in treating patients with recurrent or persistent ovarian, fallopian tube, or primary 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 |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Toxicity
- measure
- Response rate
- measure
- Quality of life
Secondary outcomes (2)
- measure
- Progression-free survival
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of ovarian, fallopian tube, or primary peritoneal cavity cancer * Recurrent or persistent platinum-refractory disease, as defined by 1 of the following: * Progressive disease while on a platinum compound * Persistent clinically measurable disease with best response as stable disease at the completion of ≥ 6 courses of therapy * Recurrent disease within 6 months after completion of therapy * Measurable or evaluable disease * Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests) * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, OR ≥ 10 mm by spiral CT scan PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-3 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN * Creatinine clearance \> 50 mL/min Other * No clinically significant infection * No other severe medical condition that would preclude study treatment * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * Prior gemcitabine or topotecan allowed provided disease is not refractory to either drug * 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
References
Publications (1)
- RESULTGoff BA, Holmberg LA, Veljovich D, Kurland BF; Puget Sound Oncology Consortium. Treatment of recurrent or persistent platinum-refractory ovarian, fallopian tube or primary peritoneal cancer with gemcitabine and topotecan: a phase II trial of the Puget Sound Oncology Consortium. Gynecol Oncol. 2008 Aug;110(2):146-51. doi: 10.1016/j.ygyno.2008.04.037. Epub 2008 Jun 6. PMID 18538834