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

Fred Hutchinson Cancer Center (FHCC)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Fallopian Tube Cancer

Peritoneal Cavity Cancer

Ovarian Cancer

Treatments

Drug: docetaxel

Drug: erlotinib hydrochloride

Drug: carboplatin

Biological: pegfilgrastim

Study type

Interventional

Funder types

Other

Identifiers

NCT00217529

PSOC-2001

PSOC-IRB-5689

CDR0000441312 (Registry Identifier)

PSOC 2001

AVENTIS-PSOC-2001

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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