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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
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

MedlinePlus related topics:   Cancer    Ovarian Cancer   

ChemIDplus related topics:   Carboplatin    Paclitaxel    Erlotinib    Erlotinib hydrochloride   

U.S. FDA Resources

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

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

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

Publications of Results:
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
First Received:   May 6, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00059787
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

Study placed in the following topic categories:
Erlotinib
Cystadenocarcinoma, Serous
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Carboplatin
Ovarian Diseases
Ovarian epithelial cancer
Fallopian Tube Neoplasms
Carcinoma
Fallopian Tube Diseases
Genital Diseases, Female
Paclitaxel
Endocrinopathy
Fallopian tube cancer
Adenocarcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Protein Kinase Inhibitors
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 05, 2008




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