Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Female
Cancer, Ovarian, Relapse, Chemotherapy

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of global response rate (complete response, partial response and stable disease)of the association topotecan-lapatinib.

Outcome Time Frame:

every two cycles of chemotherapy

Safety Issue:

Yes

Principal Investigator

Florence JOLY, MD-PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre François Baclesse

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2007-005706-44

NCT ID:

NCT00888810

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Cancer
  • Ovarian
  • Relapse
  • Chemotherapy
  • ovarian - cancer - relapse - topotecan - lapatinib

Name

Location