Trial Outcomes & Findings for Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients (NCT NCT00393861)

NCT ID: NCT00393861

Last Updated: 2016-03-24

Results Overview

The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: 12 month post completion of treatment
• Results posted on: 2016-03-24

Participant Flow

This protocol was based on getting at least 18 evaluable patients. Since the response data had looked promising, an additional 11 patients were added to obtain more accurate estimates of response.

Participant milestones

Measure	Oxaliplatin & Bevacizumab Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
Overall Study STARTED	29
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Measure	Oxaliplatin & Bevacizumab Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
Overall Study Adverse Event	2
Overall Study Disease Progression	24

Baseline Characteristics

Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients

Baseline characteristics by cohort

Measure	Oxaliplatin & Bevacizumab n=29 Participants Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.3 years STANDARD_DEVIATION 12.06 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 month post completion of treatment

Population: All patients enrolled and received treatment.

The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug.

Outcome measures

Measure	Oxaliplatin & Bevacizumab n=29 Participants Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
Twelve Month Disease-free Survival Rate	3.5 percentage of participants Interval 0.2 to 15.3

SECONDARY outcome

Timeframe: completion of study, up to 5 years

Population: All patients enrolled and received treatment.

The percent of patients having an objective response (complete or partial response) will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Oxaliplatin & Bevacizumab n=29 Participants Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
Objective Response Rate (Complete and Partial Response)	27.6 percentage of participants Interval 14.5 to 44.3

SECONDARY outcome

Timeframe: completion of study, up to 5 years

Population: All patients enrolled and received treatment.

Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.

Outcome measures

Measure	Oxaliplatin & Bevacizumab n=29 Participants Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
Duration of Remission (CR + PR)	4.7 months Interval 2.1 to 17.2

SECONDARY outcome

Timeframe: completion of study, up to 5 years

Population: All patients enrolled and received treatment.

Will be examined using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.

Outcome measures

Measure	Oxaliplatin & Bevacizumab n=29 Participants Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
Overall Survival	7.7 months Interval 5.4 to 13.4

Adverse Events

Oxaliplatin & Bevacizumab

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oxaliplatin & Bevacizumab n=29 participants at risk Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
Gastrointestinal disorders CONSTIPATION	13.8% 4/29 • beginning of treatment until the end of the study for up to 5 years
Gastrointestinal disorders HEARTBURN/DYSPEPSIA	10.3% 3/29 • beginning of treatment until the end of the study for up to 5 years
Gastrointestinal disorders NAUSEA	41.4% 12/29 • beginning of treatment until the end of the study for up to 5 years
Gastrointestinal disorders TASTE ALTERATION (DYSGEUSIA)	13.8% 4/29 • beginning of treatment until the end of the study for up to 5 years
Gastrointestinal disorders VOMITING	24.1% 7/29 • beginning of treatment until the end of the study for up to 5 years
General disorders FATIGUE (ASTHENIA, LETHARGY, MALAISE)	34.5% 10/29 • beginning of treatment until the end of the study for up to 5 years
General disorders FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	6.9% 2/29 • beginning of treatment until the end of the study for up to 5 years
General disorders INJECTION SITE REACTION/EXTRAVASATION CHANGES	6.9% 2/29 • beginning of treatment until the end of the study for up to 5 years
General disorders PAIN - OTHER	13.8% 4/29 • beginning of treatment until the end of the study for up to 5 years
Respiratory, thoracic and mediastinal disorders HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE	6.9% 2/29 • beginning of treatment until the end of the study for up to 5 years
Metabolism and nutrition disorders ANOREXIA	13.8% 4/29 • beginning of treatment until the end of the study for up to 5 years
Nervous system disorders DIZZINESS	6.9% 2/29 • beginning of treatment until the end of the study for up to 5 years
Nervous system disorders INSOMNIA	10.3% 3/29 • beginning of treatment until the end of the study for up to 5 years
Nervous system disorders NEUROPATHY: SENSORY	34.5% 10/29 • beginning of treatment until the end of the study for up to 5 years
Psychiatric disorders MOOD ALTERATION - DEPRESSION	6.9% 2/29 • beginning of treatment until the end of the study for up to 5 years
General disorders PAIN - HEAD/HEADACHE	6.9% 2/29 • beginning of treatment until the end of the study for up to 5 years
Gastrointestinal disorders PAIN - ABDOMEN NOS	6.9% 2/29 • beginning of treatment until the end of the study for up to 5 years
Respiratory, thoracic and mediastinal disorders COUGH	10.3% 3/29 • beginning of treatment until the end of the study for up to 5 years
Respiratory, thoracic and mediastinal disorders DYSPNEA (SHORTNESS OF BREATH)	6.9% 2/29 • beginning of treatment until the end of the study for up to 5 years
Skin and subcutaneous tissue disorders PRURITUS/ITCHING	6.9% 2/29 • beginning of treatment until the end of the study for up to 5 years
Vascular disorders HYPERTENSION	6.9% 2/29 • beginning of treatment until the end of the study for up to 5 years

Additional Information

Lawrence H. Einhorn, M.D.

IndianaU

Phone: (317) 944-0920

Email: leinhorn@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place