Combination Chemotherapy Plus Erlotinib in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer - Full Text View

Sponsor:	Albert Einstein College of Medicine of Yeshiva University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00059787

Purpose

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying the side effects of giving erlotinib together with carboplatin and paclitaxel and to see how well it works in treating patients with stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: carboplatin Drug: erlotinib hydrochloride Drug: paclitaxel Procedure: adjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of OSI 774 in Combination With Carboplatin and Paclitaxel in Patients With Ovarian or Primary Peritoneal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Pathologic complete response [ Designated as safety issue: No ]
Pharmacodynamics [ Designated as safety issue: No ]
Assessment of tolerance to the regimen [ Designated as safety issue: Yes ]

Estimated Enrollment:	77
Study Start Date:	April 2003

Detailed Description:

OBJECTIVES:

Primary

Determine the rate of pathologic complete response (pCR) in patients with stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with paclitaxel, carboplatin, and erlotinib.
Determine the degree and type of toxicity of this regimen in these patients.

Secondary

Correlate pCR with epidermal growth factor receptor (EGFR), p110 truncated EGFR isoform (pEGFR), and related signal transduction pathway protein expression levels in patients treated with this regimen.
Determine changes in EGFR and pEGFR levels and other related signal transduction pathway expression in patients treated with this regimen.
Determine the tolerability of twelve months of maintenance therapy with erlotinib in patients achieving pCR, and measure the progression-free interval of these patients.
Correlate the degree of skin rash with clinical and translational endpoints, through prospective documentation of cutaneous effects, in patients treated with this regimen.

OUTLINE: This is a non-randomized study. Patients are stratified according to disease stage (stage III with optimal residual disease vs stage III with suboptimal residual disease or stage IV).

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.

PROJECTED ACCRUAL: A total of 47-77 patients (28-41 for stratum I and 19-36 for stratum II) will be accrued for this study within 9-16 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary peritoneal, fallopian tube, or ovarian epithelial carcinoma, meeting 1 of the following staging criteria:
- Stage III with optimal disease after initial surgery (no more than 1 cm residual disease)
- Stage III with suboptimal disease after initial surgery
- Stage IV
Must have undergone appropriate initial surgery within the past 12 weeks OR determined to be unresectable at diagnosis
The following subtypes are eligible:
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell carcinoma
- Malignant Brenner tumor
- Adenocarcinoma not otherwise specified
No known brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST and ALT no greater than 2.5 times ULN

Renal

Creatinine no greater than 1.5 times ULN OR
Creatinine clearance at least 60 mL/min

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No HIV-positive patients receiving combination antiretroviral therapy
No history of allergic reaction to compounds of similar chemical or biologic composition to erlotinib or other study agents
No ongoing or active infection
No other uncontrolled concurrent illness
No sensory or motor neuropathy greater than grade 1
No medical contraindication to study regimen
No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 5 years since prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

See Disease Characteristics

Other

No other concurrent investigational agents
No other concurrent anticancer agents or therapies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059787

Locations

United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-2875
United States, New York
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016

Sponsors and Collaborators

Albert Einstein College of Medicine of Yeshiva University

National Cancer Institute (NCI)

Investigators

Study Chair:

Stephanie V. Blank, MD

New York University School of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Blank SV, Curtin JP, Goldman NA, et al.: Report of first-stage accrual for NCI 5886, a phase II study of erlotinib, carboplatin and paclitaxel as first-line treatment of ovarian cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-5076, 274s, 2006.

Study ID Numbers:	CDR0000271356, AECM-NYU-0230, NYU-0230, NCI-5886, NYU-1102-590
Study First Received:	May 6, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00059787 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer
ovarian clear cell cystadenocarcinoma
ovarian endometrioid adenocarcinoma

ovarian mucinous cystadenocarcinoma
ovarian serous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma
Brenner tumor
fallopian tube cancer

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Urogenital Neoplasms
Ovarian Diseases
Protein Kinase Inhibitors
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Erlotinib
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators

Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009