CompletedPhase 3ACTRN12607000071426

TARCEVA: A randomised, multicentre, phase III study of Erlotinib versus observation in patients with no evidence of disease progression after first line, platinum-based chemotherapy for high-risk Stage I and Stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.

A randomised, multicentre, phase III study of Erlotinib versus observation in patients with no evidence of disease progression after first line, platinum-based chemotherapy for high-risk Stage I and Stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer to improve progression-free survival.


Sponsor

European Organisation for Research and Treatment of Cancer

Enrollment

830 participants

Start Date

Oct 15, 2005

Study Type

Interventional

Conditions

Summary

To determine whether the administration of Erlotinib (maintenance treatment) after first line chemotherapy in patients with ovarian cancer can provide improved outcomes in terms of progression-free survival, compared with the standard approach of observation alone. Roche only will be supplying the drug.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria1

  • Histologically confirmed high-risk International Federation of Gynecology and Obstetrics (FIGO) stage I (grade 3, or aneuploid grade 1 or 2, or clear cell), or stage II-IV ovarian epithelial, primary peritoneal, and fallopian tube cancer.2.Complete response (CR) (clinical and/or pathological, i.e., no evidence of disease [NED] status), partial response (PR), or disease stabilization (SD) after first line therapy3. Eastern Cooperative Oncology Group (ECOG) 0-1. 4. Randomisation within 6 weeks of the end of first line therapy for ovarian cancer (Carboplatin or Cisplatin). 5.Adequate bone marrow, hepatic and renal functions. 6.Written informed consent.

Exclusion Criteria1

  • Adenocarcinoma of unknown origin.2.Prior or concurrent treatment with any other investigational agent3.Prior therapy targeting the epidermal growth factor receptor (EGFR)4.Prior allergic reaction to any compound chemically related to the study drug5.Previous (within the last 5 years) or concurrent malignancies6.Known history of brain metastases and/or leptomeningeal disease.7.Gastrointestinal tract disease resulting in an inability to take oral medication or requiring parenteral nutrition or affecting absorption. Active peptic ulcer disease.8.Uncontrolled bowel inflammatory disease (e.g., Crohn´s disease or ulcerative colitis).9.Myocardial infarction within the past 6 months.10.Second- or third-degree heart blocks unless pacemaker implanted.11.Significant dermatological disease.12.Inflammatory changes of the surface of the eye.13.Other significant medical condition, neurological or psychiatric disorder.14.Pregnant or lactating women (or potentially fertile women not using adequate contraception).15.Prior radiotherapy.16.Any condition potentially hampering compliance with the study protocol and follow-up schedule.

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Interventions

1)Treatment Arm: Erlotinib 150 mg orally, administered on a daily basis, up to 2 years

1)Treatment Arm: Erlotinib 150 mg orally, administered on a daily basis, up to 2 years


Locations(1)

Australia

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ACTRN12607000071426