- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00113373
Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer
A Phase II Evaluation of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES: Primary I. Determine 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with lapatinib.
II. Determine the nature and degree of toxicity of this drug in these patients.
Secondary I. Determine the clinical response rate (partial and complete response) in patients treated with this drug.
II. Determine the duration of progression-free and overall survival of patients treated with this drug.
III. 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.
IV. 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.
V. 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19103
- Gynecologic Oncology Group
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Tumor accessible by guided core needle or fine needle biopsy
- Ineligible for any higher priority Gynecologic Oncology Group (GOG) protocols (i.e., any active phase III protocol for the same patient population)
- Performance status - GOG 0-2 (patients who have received 1 prior treatment regimen)
- Performance status - GOG 0-1 (patients who have received 2 prior treatment regimens)
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Serum Glutamate Oxaloacetate Transaminase (SGOT) ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Ejection fraction normal by echocardiogram or MUGA
- 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)
- 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
- At least 4 weeks since prior immunologic agents for the malignancy
- No prior trastuzumab (Herceptin®)or cetuximab
- 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
- 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
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to > 25% of marrow-bearing areas
- See Disease Characteristics
- Recovered from prior surgery
- No prior surgical procedure affecting gastrointestinal (GI) absorption
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (lapatinib ditosylate)
Patients receive oral lapatinib once daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS) > 6 Months
Time Frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months
|
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
|
For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months
|
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0
Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment
|
Assessed every cycle while on treatment, 30 days after the last cycle of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Response
Time Frame: Baseline, every other cycle for 6 months and then every 6 months for up to 5 years
|
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.
Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.
There can be no unequivocal progression of non-target lesions and no new lesions.
Documentation by two disease assessments at least 4 weeks apart is required.
In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.
These patients will have their response classified according to the definitions stated above.
Complete and partial responses are included in the objective tumor response rate.
|
Baseline, every other cycle for 6 months and then every 6 months for up to 5 years
|
Duration of Progression-free Survival
Time Frame: Every other cycle for 6 months and then every 6 months for up to 5 years.
|
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
|
Every other cycle for 6 months and then every 6 months for up to 5 years.
|
Overall Survival
Time Frame: From entry into the study to death or the date of last contact, assessed up to 5 years
|
The observed length of life from entry into the study to death or the date of last contact.
|
From entry into the study to death or the date of last contact, assessed up to 5 years
|
Prognostic Variable: Platinum Sensitivity
Time Frame: Baseline
|
Patients who had disease progression within 6 months of ending their last regimen of platinum therapy were considered platinum resistant.
Patients who had disease progression between 6 and 12 months of ending their last platinum regimen were considered platinum sensitive.
Patients who had disease progression beyond12 months of ending their last platinum regimen were also considered platinum sensitive.
|
Baseline
|
Prognostic Variables: Performance Status
Time Frame: Baseline
|
Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities.
Up and about more than 50% of waking hours.
|
Baseline
|
Prognostic Variable: Cellular Histology
Time Frame: Baseline
|
Number of patients with Clear Cell Carcinoma or Mucinous Carcinoma
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Agustin Garcia, Gynecologic Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Recurrence
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Lapatinib
Other Study ID Numbers
- NCI-2012-02654 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA027469 (U.S. NIH Grant/Contract)
- CDR0000429548
- GOG-0170G (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Peritoneal Cavity Cancer
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage... and other conditions
-
National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIIA Primary... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Sanofi Pasteur, a Sanofi CompanyCompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIB Fallopian Tube Cancer | Stage IIIC Fallopian Tube Cancer and other conditionsCanada
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedPrimary Peritoneal Cavity Cancer | Carcinoma of the AppendixUnited States
-
National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminatedOvarian Cancer | Primary Peritoneal Cavity CancerUnited States, Canada
-
Merck Sharp & Dohme LLCTerminatedOvarian Cancer | Primary Peritoneal Cavity Cancer
-
University of VirginiaNational Cancer Institute (NCI)CompletedOvarian Cancer | Primary Peritoneal Cavity CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Cancer | Primary Peritoneal Cavity CancerUnited States, Canada
Clinical Trials on laboratory biomarker analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States