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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000071426

Acronym

EORTC TARCEVA 55041

Enrollment

855

Registered

2007-01-23

Start date

2005-10-15

Completion date

2008-02-19

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1.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 criteria

1.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.

Outcome results