Clinical trial · Interventional
Topotecan in Treating Patients With Gynecologic Cancer That Cannot Be Removed by Surgery
A Phase I Study of Weekly Oral Topotecan in Gynecologic Malignancies
NCT00842452CI-TRIAL-00009915completedPhase 1ClinicalTrials.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, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with gynecologic cancer that cannot be removed by surgery.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pharmacological study | Other | — | UNRESOLVED |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Topotecan
- interventionNames
- Drug: topotecan hydrochloride
- Other: pharmacological study
Primary outcomes (3)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
- measure
- Safety and tolerability
- timeFrame
- Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.
- measure
- Plasma concentration of topotecan hydrochloride when administered at the MTD
- timeFrame
- blood sample collection periodically on day 1 of course 1 for pharmacokinetic studies
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically\* or cytologically confirmed unresectable gynecologic malignancy for which standard curative or palliative care is not available * All tumor types allowed NOTE: \*Histologic confirmation of recurrence is not required * Measurable or nonmeasurable disease * If CT scan was used to evaluate measurable disease, lesions must be clearly defined and be ≥ 10 mm on spiral CT scan * No "borderline tumors" or tumors with low malignant potential PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy ≥ 12 weeks * ANC ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Hemoglobin ≥ 9 g/dL * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Creatinine clearance ≥ 60 mL/min * AST/ALT ≤ 2.5 times ULN (\< 5 times ULN if liver metastases are present) * Alkaline phosphatase ≤ 2.5 times ULN (\< 5 times ULN if liver metastases are present) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Adequate intestinal function (i.e., no gastrostomy tube or requirement for IV hydration or nutritional support) * No severe gastrointestinal bleeding or intestinal obstruction * No other condition that would affect gastrointestinal absorption and motility * No septicemia, severe infection, or acute hepatitis * No other malignancies requiring chemotherapy or radiotherapy within the past 5 years, except skin cancer * No concurrent severe medical problem unrelated to the malignancy that would significantly limit full compliance with the study, expose the patient to extreme risk, or decrease life expectancy PRIOR CONCURRENT THERAPY: * At least 28 days since prior investigational drugs (including cytotoxic drugs) * At least 4 weeks since prior chemotherapy, radiotherapy, biologic therapy, or surgery and recovered * No more than 3 prior chemotherapy regimens * No prior topotecan hydrochloride or other camptothecin analogs * No prior radiotherapy to \> 25% of the bone marrow * No other concurrent chemotherapy, radiotherapy, biologic therapy, immunotherapy, or hormonal therapy for cancer * No concurrent administration of any of the following: * P-glycoprotein (ABCB1, Pgp, MDR1) inhibitors or inducers * Breast cancer-resistant protein (ABCG2, BCRP, MXR) inhibitors or inducers * No concurrent chronic H2 antagonists, proton pump inhibitors, or antacids for gastritis, gastroesophageal reflux disease, or gastric or duodenal ulcers * Intermittent antacid therapy is allowed provided it is given ≥ 6 hours prior to and ≥ 90 minutes after study drug administration
References
Publications (0)
Data not yet available
No reference posted for this study.