Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate 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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over Pharmaceutical / Industry PSOC-2001 AVENTIS-PSOC-2001, PSOC-IRB-5689, NCT00217529

Objectives

Primary

1. 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

1. Determine the toxicity of maintenance therapy with erlotinib when administered after front-line therapy in these patients.
2. Determine the proportion of patients who are able to receive the full schedule of treatment courses.
3. Determine the objective response rate in patients with measurable or evaluable disease treated with this regimen.
4. Determine the progression-free and overall survival of patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Hemoglobin ≥ 8.0 g/dL
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 30 patients will be accrued for this study.

Outcomes

Maximum tolerated dose of erlotinib

Toxicity of maintenance therapy
Proportion of patients who receive the full schedule of treatment courses
Response rate
Progression-free survival
Overall survival

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.

Trial Contact Information

Trial Lead Organizations

Puget Sound Oncology Consortium at Fred Hutchinson Cancer Research Center

Leona Holmberg, MD, PhD, Protocol chair		Ph: 206-667-6447 Email: lholmber@fhcrc.org
Benjamin Greer, MD, Protocol co-chair		Ph: 206-685-2463 Email: bengreer@u.washington.edu
Dan Veljovich, MD, Protocol chair		Ph: 206-215-3200

Registry Information
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
Trial Start Date		2004-06-08
Registered in ClinicalTrials.gov		NCT00217529
Date Submitted to PDQ		2005-07-27
Information Last Verified		2006-02-03