Clinical trial · Interventional
Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer
A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung 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, such as topotecan and vinorelbine, 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 I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vinorelbine + topotecan
- interventionNames
- Drug: topotecan hydrochloride
- Drug: vinorelbine tartrate
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- Cycle 1 (up to day 21)
Secondary outcomes (3)
- measure
- Response rate
- timeFrame
- while on study, at the end of each 3 week cycle
- measure
- stable disease rate
- timeFrame
- while on study, at the end of each 3 week cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed lung cancer * All histologic types eligible * Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy PATIENT CHARACTERISTICS: * ECOG performance status (PS) ≤ 2 * Karnofsky PS ≥ 60% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Fertile patients must use effective contraception * No other active invasive malignancy * No uncontrolled illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * No psychiatric illness/social situation that would limit compliance with study requirements * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan or vinorelbine ditartrate PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 2 weeks since prior radiotherapy * No prior therapy with topotecan or vinorelbine ditartrate * No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) * Recovered from agents administered \> 4 weeks earlier * No other concurrent investigational agents * No concurrent palliative radiotherapy * No other concurrent anticancer therapies or agents * No concurrent hormones or other chemotherapy except for the following: * Steroids for adrenal failure * Hormones for nondisease-related conditions (e.g., insulin for diabetes) * Intermittent dexamethasone as an antiemetic
References
Publications (1)
- RESULTBeldner MA, Sherman CA, Green MR, Garrett-Mayer E, Chaudhary U, Meyer ML, Kraft AS, Montero AJ. Phase I dose escalation study of vinorelbine and topotecan combination chemotherapy in patients with recurrent lung cancer. BMC Cancer. 2007 Dec 20;7:231. doi: 10.1186/1471-2407-7-231. PMID 18096059