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A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Phase 3
18 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer



- Compare the benefits, in terms of progression-free survival, of maintenance therapy
comprising erlotinib vs observation in patients with responding or stable disease after
first-line, platinum-based chemotherapy for high-risk stage I or stage II-IV ovarian
epithelial, primary peritoneal, or fallopian tube cancer.


- Compare the overall survival of patients treated with these regimens.

- Determine the safety of erlotinib in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (I-II vs III-IV), participating center, age (≤ 65 vs > 65), response to
first-line therapy (no evidence of disease/complete response vs partial response vs stable
disease), and first-line therapy (platinum-based vs platinum/taxane combination vs
platinum-based triplet). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral erlotinib once daily for up to 2 years in the absence of
disease progression or unacceptable toxicity.

- Arm II: Patients undergo observation as per standard of care. Quality of life is
assessed at baseline and then every 3 months for up to 2 years.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 830 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube
cancer meeting 1 of the following criteria:

- High-risk stage I disease, as defined by grade 3, aneuploid grade 1 or 2, or
clear cell disease

- Stage II, III, or IV disease

- Completed first-line therapy within the past 6 weeks

- Received a platinum derivative (carboplatin or cisplatin) alone or in
combination with other agents for 6-9 courses

- Must have achieved complete response/no evidence of disease, partial response,
or stabilization of disease after therapy

- No adenocarcinoma of unknown origin

- No known brain metastases or leptomeningeal disease


Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Platelet count ≥ 100,000/mm^3

- WBC ≥ 2,000/mm^3


- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with
known liver metastases)

- Bilirubin ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 5 times ULN except in patients with known bone metastases

- PT and PTT ≤ 1.5 times ULN


- Creatinine ≤ 2 times ULN


- No myocardial infarction within past 6 months

- No second- or third-degree heart block without pacemaker


- No active peptic ulcer disease

- No gastrointestinal tract disease that would interfere with ability to take oral
medications, affect absorption, or require parenteral nutrition

- No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No significant dermatologic disease

- No inflammatory changes to the surface of the eye

- No history of allergic reaction to compounds of similar chemical composition as

- No other significant medical condition or neurologic or psychiatric disorder

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or cone-biopsied carcinoma in situ of the cervix

- No psychiatric illness or familial, geographic, or social situation that would
preclude study compliance


Biologic therapy

- No prior therapy targeting epidermal growth factor receptor

- No concurrent immunotherapy


- See Disease Characteristics

- See Surgery

- No concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy


- No prior radiotherapy unless completed more than 5 years ago AND outside the


- Interval debulking surgery after 3 courses of chemotherapy and second-look surgery at
the end of chemotherapy allowed as per study EORTC-55971/NCIC OV13/Chorus


- No other prior or concurrent investigational agents

- No other concurrent anticancer treatment

- Concurrent participation in study EORTC-55971/NCIC-OV13/Chorus allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:


Principal Investigator

Antonio Jimeno

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital Universitario 12 de Octubre


United States: Federal Government

Study ID:




Start Date:

September 2005

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage I ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms