|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | September 1999 | ||||
| Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003967 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer | ||||
| Official Title ICMJE | A Phase I Study of Sequential Prolonged Oral Topotecan (IND# 58,131) and Prolonged Oral Etoposide as Second Line Therapy in Ovarian, Peritoneal or Tubal Carcinoma | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of topotecan plus etoposide in treating patients who have recurrent ovarian cancer, peritoneal cancer, or fallopian tube cancer. |
||||
| Detailed Description | OBJECTIVES: I. Determine the maximum tolerated dose of sequential prolonged topotecan and prolonged etoposide as second line therapy in patients with recurrent ovarian epithelial, peritoneal, or tubal cancer. II. Determine the nature and degree of toxicity of this treatment regimen in this patient population. III. Evaluate the response rate and time to disease progression in these patients. OUTLINE: This is a dose escalation study. Patients receive oral topotecan daily on days 1-5 and oral etoposide daily on days 8-10. Courses repeat every 28 days in the absence of disease progression or unacceptable side effects. Patients achieving partial or complete response or stable disease continue treatment for at least 4-6 courses. Cohorts of 3-6 patients receive topotecan and etoposide on increasing numbers of days until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no greater than 1 of 6 patients experiences dose limiting toxicity. Patients are followed every 3 months or until death. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 12 months. |
||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * | Rose PG, Markman M, Bell JG, Fusco NL. Sequential prolonged oral topotecan and prolonged oral etoposide as second-line therapy in ovarian or peritoneal carcinoma: a phase I Gynecologic Oncology Group study. Gynecol Oncol. 2006 Aug;102(2):236-9. Epub 2006 Jan 18. | ||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Completion Date | |||||
| Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, peritoneal, or tubal cancer Epithelial cell types Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell Malignant Brenner's tumor Adenocarcinoma not otherwise specified Measurable or evaluable disease No brain or leptomeningeal metastases No symptomatic bowel involvement of ovarian cancer Not eligible for higher priority GOG phase II or III study PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT/SGPT/GGT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Other: No septicemia or severe infection Body surface area at least 1 m2 Adequate intestinal function (i.e., does not require IV hydration or nutritional support) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 3 months prior to and during study No other malignancies within the past 5 years except curatively treated skin cancer No other severe medical problems that would prevent compliance No condition of the GI tract that would affect GI absorption and motility No severe gastrointestinal bleeding PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior topotecan, other camptothecin analogs, or etoposide At least 1 prior cisplatin/paclitaxel based regimen At least 3 weeks since prior chemotherapy and recovered No more than 2 prior cytotoxic chemotherapy regimens No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy for cancer Radiotherapy: At least 3 weeks since prior radiotherapy to no more than 10% of the bone marrow and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 28 days or 5 half lives since prior investigational drugs (including cytotoxic drugs) No concurrent metoclopramide or cisapride for maintaining gastric motility or emptying No chronic H2 antagonists, proton pump inhibitors, or antacids for gastritis, gastroesophageal reflux disease, or gastric or duodenal ulcers Intermittent antacids allowed, if no antacids 6 hours prior to and 90 minutes after topotecan |
||||
| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003967 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067168, GOG-9807 | ||||
| Study Sponsor ICMJE | Gynecologic Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||