Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AVF3648s | Other Identifier | GSK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the clinical safety and toxicity of intravenous bevacizumab (Days 1 and 15 of a 28 day cycle) in combination with weekly topotecan (Days 1, 8, 15 of a 28 day cycle) in patients with platinum resistant recurrent ovarian, fallopian tube and primary peritoneal cancer.
This study is designed as a Phase 2 study. There are no published data on the toxicity of the combination of bevacizumab and topotecan therapy. Based on data combining bevacizumab with other chemotherapy agents in non-gynecologic solid tumors, it is not likely that the toxicity of the combination of the two drugs will be greater than the individual toxicities of each drug. The toxicities of each of these agents is quite different. Specifically the toxicity of this combination will be studied using the dose of bevacizumab used in previous phase II studies of ovarian cancer, e.g. an equivalent of 5 mg/kg weekly with treatments given at least every 3 weeks. In our study, since topotecan will be given weeks 1,2 and 3 of an every 4 week cycle, it is convenient to give bevacizumab 10 mg/kg IV every other week.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Subjects received standard topotecan with the addition of bevacizumab. Cycles were 28 days and continued until toxicity, progression or subject wish to discontinue treatment. Topotecan administered 4 mg/m2 IV on days 1, 8 and 15 and bevacizumab IV 10 mg/kg, days 1 and 15 of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topotecan | Drug | Topotecan administered days 1, 8, and 15 of each 28 day cycle. Dose was 4 mg/m2 administered IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively. | PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Overall Survival | Overall survival was defined as the number of months after commencing study treatment to death. | PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. |
| Objective Response Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathryn McGonigle, MD | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States | ||
| Puget Sound Oncology Consortium (PSOC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21815133 | Result | McGonigle KF, Muntz HG, Vuky J, Paley PJ, Veljovich DS, Greer BE, Goff BA, Gray HJ, Malpass TW. Combined weekly topotecan and biweekly bevacizumab in women with platinum-resistant ovarian, peritoneal, or fallopian tube cancer: results of a phase 2 study. Cancer. 2011 Aug 15;117(16):3731-40. doi: 10.1002/cncr.25967. Epub 2011 Feb 24. |
| Label | URL |
|---|---|
| Benaroya Research Institute's homepage with listings of clinical trials | View source |
Not provided
Women had advanced or recurrent epithelial ovarian, peritoneal, or fallopian tube cancer. Enrollment was restricted to women who had received a maximum of two prior chemotherapy regimens, with at least one prior primary taxane and platinum-based therapy.
Subjects enrolled from August 2006 to November 2008, in the medical oncoogy practices at Virginia Mason Medical Center and the Puget Sound Oncology Consortium in Seattle, WA.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Combined Weekly Topotecan and Biweekly Bevacizumab | Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Combined Weekly Topotecan and Biweekly Bevacizumab | Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively. | This was determined assuming a median progression free survival of 9 months and an analysis calculating the sample size at which the narrowing of its 95% confidence interval became greater than .20 for every 2 patients added. Progression free survival and overall survival were estimated by using the Kaplan Meier method. | Posted | Median | 95% Confidence Interval | months | PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. |
|
Adverse event collecting occurred from first subject enrolled through January 31, 2010.
All patients had been previously treated with platinum (carboplatin or cisplatin) and a taxane (paclitaxel or docetaxel. Toxicity was generally mild or moderate. No treatment related death occurred.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Patients (N=40) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Other | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Other | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Malpass, M.D., Principal Investigator | Benaroya Research Institute at Virginia Mason | 206-223-6193 | thomas.malpass@vmmc.org |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019772 | Topotecan |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bevacizumab | Drug | bevacizumab administered IV 10 mg/kg, days 1 and 15 of 28 day cycle. |
|
|
RECIST criteria |
| Response |
| Number or Participants With Toxicity | measured at each treatment cycle |
| Seattle |
| Washington |
| 98104 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted. |
|
|
|
| Secondary | Evaluation of Overall Survival | Overall survival was defined as the number of months after commencing study treatment to death. | The planned enrollment of 40 participants was determined using a median PFS of 9 months (based on a median PFS of 7.2 months in a previous trial). | Posted | Median | 95% Confidence Interval | months | PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death. |
|
|
|
|
| Secondary | Objective Response Rate | RECIST criteria | Posted | Number | participants | Response |
|
|
|
| Secondary | Number or Participants With Toxicity | Posted | Number | participants | measured at each treatment cycle |
|
|
|
| 9 |
| 40 |
| 38 |
| 40 |
| Bowel obstruction | Gastrointestinal disorders | Other | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Other | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Other | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | Other | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Other | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Other | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Other | Systematic Assessment |
|
| Fatigue | General disorders | Other | Systematic Assessment |
|
| Pain | General disorders | Other | Systematic Assessment |
|
| Nausea/Vomiting/Diarrhea | Gastrointestinal disorders | Other | Systematic Assessment |
|
| infection | Infections and infestations | Other | Systematic Assessment |
|
| Depression | Psychiatric disorders | Other | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Other | Systematic Assessment |
|
| GGT increased | Investigations | Other | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Other | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | Other | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Other | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Other | Systematic Assessment |
|
| Vasovagal reaction | Nervous system disorders | Other | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Other | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | Other | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Other | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Other | Systematic Assessment |
|
| Headache | Nervous system disorders | Other | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Other | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Other | Systematic Assessment |
|
| Gastroesophageal reflux | Gastrointestinal disorders | Other | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Other | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Other | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | Other | Systematic Assessment |
|
| Oral mucositis | Gastrointestinal disorders | Other | Systematic Assessment |
|
| Malaise | General disorders | Other | Systematic Assessment |
|
| Chills | General disorders | Other | Systematic Assessment |
|
| Weight loss | Investigations | Other | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Other | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Other | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Other | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Other | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | Other | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | Other | Systematic Assessment |
|
| Alanine aminotransferase | Investigations | Other | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Other | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Other | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | Other | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Other | Systematic Assessment |
|
| Cholesterol high | Investigations | Other | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Other | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Other | Systematic Assessment |
|
Not provided
Not provided
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D000911 |
| Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|