Clinical trial · Interventional
Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer
A Phase II Study Evaluating the Association of Topotecan and Lapatinib in Early Recurrent (Less Than 12 Months)Ovarian or Peritoneal Cancer Patients After First Line of Platinum-Based Chemotherapy
NCT00888810CI-TRIAL-00002255TOPO-LAPAterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of efficacy (intermediate analysis)
Summary
Brief summary (as posted)
The objective of the trial was to evaluate the efficacy of the association of topotecan and lapatinib in patients who failed first line platinum-based chemotherapy within 12 months.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chemotherapy | — | UNRESOLVED | — |
| Ovarian | — | UNRESOLVED | — |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib.
- timeFrame
- every two cycles of chemotherapy
Secondary outcomes (1)
- measure
- Global survival rate, survival rate without progression, response time, time without progression, safety, quality of life, Caracterisation of biological response (tumor, ascite and blood samples)
- timeFrame
- each cycle of chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age superior or equal 18 years * primitive ovarian adenocarcinoma histologically confirmed * or peritoneal or fallopian tube adenocarcinoma histologically confirmed * Progression or relapse within 12 months after the end of first line of platin based chemotherapy * association in first line with other anticancer agent is allowed (taxanes, anthracyclines, alkylants or gemcitabine) and with an anti-angiogenic (bevacizumab, sunitinib). * intra-peritoneal chemotherapy in first line is possible * No previous treatment with HER inhibitors (ex : gefitinib) * HER status not necessary * measurable lesions (RECIST criteria). and/or CA125 value higher than 2 fold the normal value or CA125 higher than 2 fold nadir value (if no normalized) proved by two samples distant of 1 month * OMS inferior or equal 2. * biological parameters as follow: creatininemia ≤ 150 µmol/L or clearance ≥ 50 mL/min,bilirubin ≤ 1,5 LNS,transaminases and or alcalin phosphatases ≤ 2 LNS without hepatic metastasis or ≤ 3 LNS if hepatic metastasis,neutrophils ≥ 1,5.109/L,plaquettes ≥ 100.109/L. * normal FEV * No previous treatment by chemotherapy, hormonotherapy, immunotherapy or radiotherapy within 4 weeks before inclusion * No concomitant treatment forbidden with lapatinib. * No previous treatment by Amiodarone in 6 months before inclusion * signed informed consent Exclusion Criteria: * Previous treatment with : * intensive chemotherapy with autograft * two lignes of chemotherapy * previous total abdominal irradiation * previous chemotherapy with anti-HER treatment * History of brain or meningitis metastasis uncontrolled. * Malignancies except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer. * uncontrolled infectious pathology * uncontrolled cardiovascular disease * Patients with an active intestinal occlusion not permit oral treatment * known hypersensibility to topotecan and its excipients * Woman of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period * Individual deprived of liberty
References
Publications (0)
Data not yet available
No reference posted for this study.