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

Brief Title

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

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

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.

Detailed Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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 Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Maximum tolerated dose of erlotinib

Secondary Outcome

 Toxicity of maintenance therapy

Condition

Fallopian Tube Cancer

Intervention

pegfilgrastim

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

Biological

Start Date

June 2004

Primary Completion Date

November 2005

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  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

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  GOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Hemoglobin ≥ 8.0 g/dL

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  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

        Renal

          -  Creatinine ≤ 2.0 mg/dL

          -  Creatinine clearance > 50 mL/min

          -  No renal disease that would preclude study participation

        Cardiovascular

          -  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

        Other

          -  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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior immunotherapy for this malignancy

        Chemotherapy

          -  No prior chemotherapy for this malignancy

        Endocrine therapy

          -  No prior hormonal therapy for this malignancy

        Radiotherapy

          -  No prior radiotherapy for this malignancy

        Surgery

          -  See Disease Characteristics

          -  No planned interval cytoreductive surgery

               -  Second-look surgery allowed

        Other

          -  More than 1 year since prior experimental or investigational therapy

          -  No concurrent therapeutic anticoagulation with warfarin

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Leona A. Holmberg, MD, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00217529

Organization ID

PSOC 2001

Secondary IDs

PSOC-2001

Study Sponsor

Fred Hutchinson Cancer Research Center

Study Sponsor

Leona A. Holmberg, MD, PhD, Study Chair, Fred Hutchinson Cancer Research Center

Verification Date

September 2010