Clinical trial · Interventional
Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
A Phase I Study of Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies
- 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)
Currently, no data exists regarding the safety and tolerability of a combination regimen utilizing weekly topotecan in combination with pemetrexed. Although both drugs are associated with myelosuppression, it is hoped that the utilization of the weekly topotecan dosing schedule will allow the drugs to be easily combined. This phase I trial will evaluate the safety and tolerability of weekly topotecan in combination with pemetrexed in patients with advanced solid tumors.
Conditions
Conditions (4)
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 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed | Drug | Pemetrexed | ALIAS |
| topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- maximum tolerated doses of drugs in combination
- measure
- overall toxicity of drug combination
- measure
- preliminary antitumor activity of drug combination
- measure
- impact of pemetrexed on topotecan pharmacokinetics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven advanced solid tumors * Measurable or evaluable disease * Age ≥ 18 years * Karnofsky performance status ≥ 80% (ECOG 0 or 1) * Adequate liver, bone marrow and kidney function Exclusion Criteria: * More than 3 prior chemotherapy regimens in the metastatic setting * Prior treatment with topotecan or pemetrexed * Clinically significant third space fluid present at the time of treatment * Unable to interrupt aspirin, other non-steroidal anti-inflammatory drugs * Inability to take steroid premedications or vitamin supplementation * The presence of active brain metastases * Prior radiotherapy within 4 weeks prior to the first day of treatment * Prior surgery within 3 weeks prior to the first day of treatment * Prior chemotherapy within 3 weeks prior to the first day of treatment
References
Publications (0)
Data not yet available