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Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer
This study is ongoing, but not recruiting participants.
First Received: June 7, 2005   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00113373
  Purpose

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: lapatinib ditosylate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Evaluation of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989, IND # 70,252) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity by NCI CTCAE v 3.0 every 4 weeks [ Designated as safety issue: Yes ]
  • Response rate by GOG RECIST criteria every 8 weeks [ Designated as safety issue: No ]
  • Duration of progression-free and overall survival [ Designated as safety issue: No ]

Study Start Date: May 2005
Estimated Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with lapatinib.
  • Determine the nature and degree of toxicity of this drug in these patients.

Secondary

  • Determine the clinical response rate (partial and complete response) in patients treated with this drug.
  • Determine the duration of progression-free and overall survival of patients treated with this drug.
  • Determine the impact of prognostic variables, including platinum sensitivity, performance status, and cellular histology (clear cell or mucinous type), on patients treated with this drug.
  • Correlate tumor levels of expression of epidermal growth factor receptors (EGFR), phosphorylated EGFR, HER2/neu, and Ki-67, as determined by immunohistochemistry, with clinical response in patients treated with this drug.
  • Correlate EGFR mutations in tumor DNA with clinical response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-26 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed persistent or recurrent ovarian epithelial or primary peritoneal cancer
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • Presence of ≥ 1 target lesion

      • Tumors within a previously irradiated field are not considered target lesions unless evidence of progression is documented or proven by biopsy 3 months after completion of radiotherapy
  • Disease progression during OR persistent disease after 1 prior platinum-based chemotherapy regimen* for primary disease containing carboplatin, cisplatin, or another organoplatinum compound

    • Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment
    • Treatment-free interval after platinum-based chemotherapy < 12 months NOTE: *One additional prior cytotoxic regimen for recurrent or persistent disease that occurred during or after platinum-based chemotherapy allowed
  • Tumor accessible by guided core needle or fine needle biopsy
  • Ineligible for any higher priority Gynecologic Oncology Group protocols (i.e., any active phase III protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-2 (patients who have received 1 prior treatment regimen)
  • GOG 0-1 (patients who have received 2 prior treatment regimens)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • Ejection fraction normal by echocardiogram or MUGA

Gastrointestinal

  • No GI disease resulting in an inability to take oral medication
  • No malabsorption syndrome
  • No requirement for IV alimentation
  • No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
  • No active infection requiring antibiotics
  • No sensory or motor neuropathy > grade 1
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to lapatinib

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior immunologic agents for the malignancy
  • No prior trastuzumab (Herceptin®) or cetuximab

Chemotherapy

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • At least 6 weeks since prior nitrosoureas or mitomycin for the malignancy
  • No prior non-cytotoxic chemotherapy for recurrent or persistent disease

Endocrine therapy

  • At least 2 weeks since prior and no concurrent dexamethasone or dexamethasone equivalent dose > 1.5 mg/day
  • At least 1 week since prior hormonal therapy for the malignancy
  • Concurrent hormone replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No prior radiotherapy to > 25% of marrow-bearing areas

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery
  • No prior surgical procedure affecting gastrointestinal (GI) absorption

Other

  • At least 4 weeks since other prior therapy for the malignancy
  • At least 6 months since prior and no concurrent amiodarone
  • At least 1 week since other prior and no concurrent CYP3A4 inhibitors
  • At least 2 weeks since prior and no concurrent CYP3A4 inducers
  • At least 1 week since prior and no concurrent H2 inhibitors or proton pump inhibitors

    • Concurrent antacids allowed provided they are not administered within 1 hour before and 1 hour after study drug administration
  • No prior cancer treatment that would preclude study treatment
  • No prior lapatinib
  • No other prior target-specific therapy directed to the HER family (e.g., gefitinib or erlotinib)
  • No concurrent herbal medications
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113373

  Show 46 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Agustin Garcia, MD Premiere Oncology
Investigator: Deborah K. Armstrong, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000429548, GOG-0170G
Study First Received: June 7, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00113373     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Lapatinib
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Abdominal Neoplasms
Protein Kinase Inhibitors
Recurrence
Carcinoma
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Lapatinib
Urogenital Neoplasms
Ovarian Diseases
Abdominal Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on August 30, 2009