Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer

Brief Title

Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer

Official Title

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

Brief Summary

      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Sometimes after treatment, the tumor may not need additional
      treatment until it progresses. In this case, observation may be sufficient. It is not yet
      known whether erlotinib is more effective than observation after first-line chemotherapy in
      treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.

      PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works
      compared to observation in treating patients who have undergone first-line chemotherapy for
      ovarian cancer, peritoneal cancer, or fallopian tube cancer.

Detailed Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Progression-free survival

Secondary Outcome

 Overall survival

Condition

Fallopian Tube Cancer

Intervention

erlotinib hydrochloride

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

September 2005

Primary Completion Date

February 2008

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  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

        PATIENT CHARACTERISTICS:

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Platelet count ≥ 100,000/mm^3

          -  WBC ≥ 2,000/mm^3

        Hepatic

          -  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

        Renal

          -  Creatinine ≤ 2 times ULN

        Cardiovascular

          -  No myocardial infarction within past 6 months

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

        Gastrointestinal

          -  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
             colitis)

        Other

          -  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
             erlotinib

          -  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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior therapy targeting epidermal growth factor receptor

          -  No concurrent immunotherapy

        Chemotherapy

          -  See Disease Characteristics

          -  See Surgery

          -  No concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormonal therapy

        Radiotherapy

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

        Surgery

          -  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

        Other

          -  No other prior or concurrent investigational agents

          -  No other concurrent anticancer treatment

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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Antonio Jimeno, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT00263822

Organization ID

EORTC-55041

Secondary IDs

EORTC-55041

Responsible Party

Sponsor

Study Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Study Sponsor

Antonio Jimeno, Study Chair, Hospital Universitario 12 de Octubre

Verification Date

August 2013