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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Thank you

Trial Information

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


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.


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 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)

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

An analysis of any potential treatment effect on PFS or overall survival may be conducted against historical controls using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Agustin Garcia

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02654

NCT ID:

NCT00113373

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103