Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00217529
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 21, 2010
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with docetaxel and carboplatin may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with docetaxel and carboplatin and to see how well they work in treating patients with newly diagnosed stage III or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Biological: pegfilgrastim Drug: carboplatin Drug: docetaxel Drug: erlotinib hydrochloride Phase 1 Phase 2

Detailed Description:



  • Determine the maximum tolerated dose (MTD) of erlotinib when administered in combination with docetaxel and carboplatin as front-line therapy in patients with newly diagnosed stage III or IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.


  • Determine the toxicity of maintenance therapy with erlotinib when administered after front-line therapy in these patients.
  • Determine the proportion of patients who are able to receive the full schedule of treatment courses.
  • Determine the objective response rate in patients with measurable or evaluable disease treated with this regimen.
  • Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of erlotinib.

  • Front-line therapy: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1, pegfilgrastim subcutaneously on day 2, and oral erlotinib once daily on days 3-16. Treatment repeats every 21 days for up to 6 courses.

Cohorts of 5 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose-limiting toxicity.

  • Maintenance therapy: Beginning 3-4 weeks after the completion of front-line therapy, patients with stable or responding disease receive oral erlotinib once daily for up to 12 months.

After completion of study treatment, patients are followed every 6 months for 1 year and then periodically thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I-II Study of OSI-774 (Tarceva, Erlotinib) With Docetaxel/Carboplatin Followed by Maintenance Therapy With Tarceva as Treatment for Newly Diagnosed Stage III/IV Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer
Study Start Date : June 2004
Actual Primary Completion Date : November 2005

Primary Outcome Measures :
  1. Maximum tolerated dose of erlotinib

Secondary Outcome Measures :
  1. Toxicity of maintenance therapy
  2. Proportion of patients who receive the full schedule of treatment courses
  3. Response rate
  4. Progression-free survival
  5. Overall survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer

    • Stage III or IV disease
  • The following histologic epithelial cell types are allowed:

    • Serous adenocarcinoma
    • Mucinous adenocarcinoma
    • Clear cell adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mixed epithelial carcinoma
    • Undifferentiated carcinoma
    • Transitional cell carcinoma
    • Malignant Brenner tumor
    • Adenocarcinoma not otherwise specified
  • Must have undergone appropriate surgery for ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer within the past 6 weeks
  • No borderline ovarian tumor of low malignant potential



  • 18 and over

Performance status

  • GOG 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin normal
  • Meets 1 of the following criteria:

    • Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST or ALT normal
  • No hepatic disease that would preclude study participation


  • Creatinine ≤ 2.0 mg/dL
  • Creatinine clearance > 50 mL/min
  • No renal disease that would preclude study participation


  • LVEF ≥ lower limit of normal*
  • No poorly controlled arrhythmia
  • No unstable coronary artery disease
  • No myocardial infarction within the past year NOTE: *LVEF evaluation performed only on patients requiring it


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No peripheral neuropathy ≥ grade 2
  • No other nonmalignant systemic disease that would preclude study participation
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No medical, social, or psychosocial factor that would preclude study participation
  • No psychiatric or addictive disorder that would preclude giving informed consent
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast


Biologic therapy

  • No prior immunotherapy for this malignancy


  • No prior chemotherapy for this malignancy

Endocrine therapy

  • No prior hormonal therapy for this malignancy


  • No prior radiotherapy for this malignancy


  • See Disease Characteristics
  • No planned interval cytoreductive surgery

    • Second-look surgery allowed


  • More than 1 year since prior experimental or investigational therapy
  • No concurrent therapeutic anticoagulation with warfarin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00217529

United States, Washington
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Study Chair: Leona A. Holmberg, MD, PhD Fred Hutchinson Cancer Research Center
Study Chair: Dan Veljovich, MD Pacific Gynecology Specialists Identifier: NCT00217529     History of Changes
Other Study ID Numbers: PSOC 2001
CDR0000441312 ( Registry Identifier: PDQ )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by Fred Hutchinson Cancer Research Center:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer
ovarian clear cell cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian undifferentiated adenocarcinoma
ovarian mucinous cystadenocarcinoma
ovarian serous cystadenocarcinoma
Brenner tumor
fallopian tube cancer
ovarian mixed epithelial carcinoma

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors