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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

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 CenterSeattle, Washington  98109
University of Washington School of MedicineSeattle, Washington  98195
Pacific Gynecology SpecialistsSeattle, Washington  98104