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