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
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of erlotinib
Safety Issue:
Yes
Principal Investigator
Leona A. Holmberg, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
PSOC 2001
NCT ID:
NCT00217529
Start Date:
June 2004
Completion Date:
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Peritoneal Cavity Cancer
- 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
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| University of Washington School of Medicine | Seattle, Washington 98195 |
| Pacific Gynecology Specialists | Seattle, Washington 98104 |
