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

NCT00888810 | Terminated Phase 2 DMC

• 1 other identifier: 2007-005706-44
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 21

Brief Summary

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

Cancer; Ovarian; Relapse; Chemotherapy

Keywords

ovarian - cancer - relapse - topotecan - lapatinib

Outcome Measures

Primary Outcomes (1)

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

  every two cycles of chemotherapy

Secondary Outcomes (1)

• 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

Interventions

TOPOTECAN DRUG

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)

Also known as: HYCAMTIN

LAPATINIB DRUG

Daily oral administration during all the study. 1250 mg/day

Also known as: TYVERB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 concomitant treatment forbidden with lapatinib.
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• GlaxoSmithKline: collaborator
• Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète: collaborator

Study Sites (21)

Centre François Baclesse

Caen, CALVADOS, 14076, France

Location

Centre Paul Papin

Angers, 49933, France

Location

CHU Jean MINJOZ

Besançon, 25030, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre G-F Leclerc

Dijon, 21076, France

Location

CHD Les Oudairies

La Roche-sur-Yon, 85025, France

Location

Centre Jean Bernard

Le Mans, 72015, France

Location

Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre azuréen de cancérologie

Mougins, 06250, France

Location

Centre Alexis vautrin

Nancy, 54511, France

Location

Centre Catherine de Sienne

Nantes, 44202, France

Location

Centre René Gauducheau

Nantes, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hôpital Diaconesses

Paris, 75012, France

Location

Institut CURIE

Paris, 75231, France

Location

APHP Hopital TENON

Paris, 75970, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Institut de Cancérologie de la Loire

Saint-Etienne, 42271, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Institut Claudius regaud

Toulouse, 31052, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Links

• French National Protocol Registration System

MeSH Terms

Conditions

Neoplasms; Recurrence

Interventions

Topotecan; Lapatinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Florence JOLY, MD-PHD

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 28, 2009
• Study Start: March 1, 2008
• Last Updated: April 28, 2009

Record last verified: 2009-04

Locations

FR (21)