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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00029 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000363562 | |||
| MC0261 | Other Identifier | Mayo Clinic | |
| 5876 | Other Identifier | CTEP | |
| N01CM62205 | U.S. NIH Grant/Contract | View source | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying how well giving cisplatin together with flavopiridol works in treating patients with advanced ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy, such as cisplatin and flavopiridol, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
OBJECTIVES:
I. Determine the response rate, time to progression, and survival in patients with advanced ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol.
II. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are accrued to two separate groups (Group 2 closed to accrual as of 3/10/06) .
GROUP 1: Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
GROUP 2 (Closed to accrual as of 3/10/06): Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
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| Group 2 | Experimental | Patients receive cisplatin IV over 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Given IV |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) | A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Will be estimated using the method of Kaplan-Meier. | Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years |
| Time to Progression | Time to progression will be estimated using the method of Kaplan-Meier. Progression is defined as having at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
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Inclusion Criteria:
Advanced disease
Meets at least 1 of the following criteria:
Treated with 1, and only 1, prior platin-containing chemotherapy regimen (e.g., paclitaxel or carboplatin-based) for ovarian epithelial or primary peritoneal cancer
Prior treatment with the same regimen at first relapse allowed;
Group 1, meeting 1 of the following criteria:
Group 2 (Closed to accrual as of 3/10/06):
No CNS metastases
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Not pregnant or nursing
Negative pregnancy test
More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
More than 3 weeks since prior radiotherapy
Recovered from all prior therapy
Fertile patients must use effective contraception
No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix
No diabetes
No peripheral neuropathy >= grade 2
No baseline diarrhea (>= 4 stools/day)
No uncontrolled infection
No other concurrent uncontrolled serious medical condition
No concurrent routine colony-stimulating factors
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| Name | Affiliation | Role |
|---|---|---|
| Keith Bible | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22664059 | Derived | Bible KC, Peethambaram PP, Oberg AL, Maples W, Groteluschen DL, Boente M, Burton JK, Gomez Dahl LC, Tibodeau JD, Isham CR, Maguire JL, Shridhar V, Kukla AK, Voll KJ, Mauer MJ, Colevas AD, Wright J, Doyle LA, Erlichman C; Mayo Phase 2 Consortium (P2C); North Central Cancer Treatment Group (NCCTG). A phase 2 trial of flavopiridol (Alvocidib) and cisplatin in platin-resistant ovarian and primary peritoneal carcinoma: MC0261. Gynecol Oncol. 2012 Oct;127(1):55-62. doi: 10.1016/j.ygyno.2012.05.030. Epub 2012 Jun 1. |
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Participants who progressed or relapsed during or within 6 months of primary platinum-based therapy constituted Group 1 ("Platin Resistant"). Participants who relapsed > 6 months following completion of platinum-based therapy, and who had received only a single prior chemotherapy regimen constituted Group 2 ("Platin Sensitive").
Forty-five patients were enrolled between December 23, 2004 and February 25, 2010: 40 patients to Group 1 (platin resistant; 14 evaluable, 26 measurable) and 5 patients to Group 2 (platin sensitive; 1 evaluable, 4 measurable). Group 2 was closed on 03/10/2006 due to poor accrual.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (Platin Resistant) | Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
| FG001 | Group 2 (Platin Sensitive) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| alvocidib | Drug | Given IV |
|
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| cisplatin/flavopiridol | Drug | Given IV |
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| Time from registration to the date of progression or last follow-up, assessed up to 3 years |
Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Platin Resistant) | Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
| BG001 | Group 2 (Platin Sensitive) | Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR) | A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart. | All 45 participants were analyzed. | Posted | Number | Percentage of Participants | 24 weeks |
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| Secondary | Overall Survival | Will be estimated using the method of Kaplan-Meier. | All 40 participants in Group 1 were analyzed for this primary endpoint. However, due to the low accrual and early group 2 closure, Group 2 was not statistically evaluated for this endpoint. | Posted | Median | 95% Confidence Interval | months | Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years |
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| Secondary | Time to Progression | Time to progression will be estimated using the method of Kaplan-Meier. Progression is defined as having at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | All 40 participants from Group 1 were analyzed. However, due to slow accrual and early closure, Group 2 was not statistically analyzed for this endpoint. | Posted | Median | 95% Confidence Interval | months | Time from registration to the date of progression or last follow-up, assessed up to 3 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 and Group 2 Combined | Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. | 23 | 45 | 45 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 6 | Systematic Assessment |
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| Hearing impaired | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 6 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
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| Fever | General disorders | MedDRA 6 | Systematic Assessment |
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| Gallbladder obstruction | Hepatobiliary disorders | MedDRA 6 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 6 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
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| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Sweating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 6 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 6 | Systematic Assessment |
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| Hearing impaired | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
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| Hearing test abnormal | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
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| Pain | General disorders | MedDRA 6 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
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| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | MedDRA 6 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 6 | Systematic Assessment |
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| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
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| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
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| Weight loss | Investigations | MedDRA 6 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Blood uric acid increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum calcium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum magnesium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Body odor | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 6 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith C. Bible, M.D, Ph.D. | Mayo Clinic Cancer Center | Bible.Keith@mayo.edu |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| 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 |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| C077990 | alvocidib |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Male |
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| Participants |
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