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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00113373 |
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 |
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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 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease
Presence of ≥ 1 target lesion
Disease progression during OR persistent disease after 1 prior platinum-based chemotherapy regimen* for primary disease containing carboplatin, cisplatin, or another organoplatinum compound
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 1 week since prior and no concurrent H2 inhibitors or proton pump inhibitors
Study Chair: | Agustin Garcia, MD | Premiere Oncology |
Investigator: | Deborah K. Armstrong, MD | Sidney Kimmel Comprehensive Cancer Center |
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 |
recurrent ovarian epithelial cancer peritoneal cavity cancer |
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 |
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 |