Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer, Ovarian, Relapse, Chemotherapy

Intervention / Treatment
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* Drug: TOPOTECAN
* Drug: LAPATINIB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TOPOTECAN|IV administration on Day 1, day 8 and day 15, at the dose level of 3.2 mg/m² for 6 cycles of 28 days(up to 8 cycles)|
|Drug: LAPATINIB|Daily oral administration during all the study. 1250 mg/day|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib. |  | every two cycles of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | each cycle of chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian - cancer - relapse - topotecan - lapatinib