Trial Outcomes & Findings for Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer (NCT NCT00083122)
NCT ID: NCT00083122
Last Updated: 2014-05-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
24 weeks
Results posted on
2014-05-21
Participant Flow
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.
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").
Participant milestones
| Measure |
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.
|
Group 2 (Platin Sensitive)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
5
|
|
Overall Study
COMPLETED
|
40
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Group 1 (Platin Resistant)
n=40 Participants
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.
|
Group 2 (Platin Sensitive)
n=5 Participants
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.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
61 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
5 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All 45 participants were analyzed.
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.
Outcome measures
| Measure |
Group 1 (Platin Resistant)
n=40 Participants
Patients receive 60 mg/m\^2 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.
|
Group 2 (Platin Sensitive)
n=5 Participants
Patients receive 60 mg/m\^2 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.
|
|---|---|---|
|
Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)
Complete Response (CR)
|
2.5 Percentage of Participants
|
0 Percentage of Participants
|
|
Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)
Partial Response (PR)
|
15 Percentage of Participants
|
40 Percentage of Participants
|
SECONDARY outcome
Timeframe: Time from registration to date of last follow-up or death due to any cause, assessed up to 3 yearsPopulation: 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.
Will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Group 1 (Platin Resistant)
n=40 Participants
Patients receive 60 mg/m\^2 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.
|
Group 2 (Platin Sensitive)
Patients receive 60 mg/m\^2 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.
|
|---|---|---|
|
Overall Survival
|
17.5 months
Interval 10.8 to 24.5
|
—
|
SECONDARY outcome
Timeframe: Time from registration to the date of progression or last follow-up, assessed up to 3 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Group 1 (Platin Resistant)
n=40 Participants
Patients receive 60 mg/m\^2 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.
|
Group 2 (Platin Sensitive)
Patients receive 60 mg/m\^2 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.
|
|---|---|---|
|
Time to Progression
|
4.3 months
Interval 2.89 to 5.81
|
—
|
Adverse Events
Group 1 and Group 2 Combined
Serious events: 23 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 and Group 2 Combined
n=45 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/45 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.2%
1/45 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
8.9%
4/45 • Number of events 4
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
6.7%
3/45 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
3/45 • Number of events 3
|
|
General disorders
Chest pain
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Fatigue
|
4.4%
2/45 • Number of events 2
|
|
General disorders
Fever
|
4.4%
2/45 • Number of events 3
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
2.2%
1/45 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
6.7%
3/45 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Creatinine increased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
8.9%
4/45 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
4.4%
2/45 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
4.4%
2/45 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Syncope
|
4.4%
2/45 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
4.4%
2/45 • Number of events 2
|
Other adverse events
| Measure |
Group 1 and Group 2 Combined
n=45 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
93.3%
42/45 • Number of events 179
|
|
Cardiac disorders
Palpitations
|
4.4%
2/45 • Number of events 2
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.4%
2/45 • Number of events 3
|
|
Ear and labyrinth disorders
Hearing test abnormal
|
2.2%
1/45 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
3/45 • Number of events 15
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.7%
3/45 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhea
|
68.9%
31/45 • Number of events 123
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
1/45 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
2/45 • Number of events 4
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/45 • Number of events 5
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
5/45 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
93.3%
42/45 • Number of events 153
|
|
Gastrointestinal disorders
Vomiting
|
71.1%
32/45 • Number of events 93
|
|
General disorders
Fatigue
|
97.8%
44/45 • Number of events 165
|
|
General disorders
Pain
|
4.4%
2/45 • Number of events 7
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
15/45 • Number of events 37
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
9/45 • Number of events 15
|
|
Investigations
Blood bilirubin increased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Creatinine increased
|
26.7%
12/45 • Number of events 29
|
|
Investigations
Leukocyte count decreased
|
31.1%
14/45 • Number of events 30
|
|
Investigations
Neutrophil count decreased
|
73.3%
33/45 • Number of events 59
|
|
Investigations
Platelet count decreased
|
62.2%
28/45 • Number of events 90
|
|
Investigations
Weight loss
|
6.7%
3/45 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
12/45 • Number of events 18
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
71.1%
32/45 • Number of events 74
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
4.4%
2/45 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
15.6%
7/45 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
13.3%
6/45 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
2.2%
1/45 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
53.3%
24/45 • Number of events 77
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
4.4%
2/45 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
4.4%
2/45 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
24.4%
11/45 • Number of events 13
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
22.2%
10/45 • Number of events 21
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/45 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
4.4%
2/45 • Number of events 5
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.2%
1/45 • Number of events 2
|
|
Nervous system disorders
Headache
|
6.7%
3/45 • Number of events 4
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.7%
3/45 • Number of events 10
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
73.3%
33/45 • Number of events 114
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.2%
1/45 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
9/45 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Body odor
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.4%
2/45 • Number of events 8
|
|
Vascular disorders
Hypertension
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
8.9%
4/45 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60