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Trial Outcomes & Findings for Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients (NCT NCT00583622)

NCT ID: NCT00583622

Last Updated: 2013-05-21

Results Overview

Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Up to 6 Months

Results posted on

2013-05-21

Participant Flow

Recruitment Period: December 19, 2007 to January 11, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

One participant of the 13 enrolled did not receive treatment and was excluded from the study.

Participant milestones

Participant milestones
Measure
Bevacizumab + High-Dose Chemotherapy
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m\^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m\^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m\^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
Overall Study
STARTED
12
Overall Study
COMPLETED
12
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Bevacizumab + High-Dose Chemotherapy
n=12 Participants
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m\^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m\^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m\^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
Age Continuous
47 years
n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 Months

Population: Due to the small number of patients treated, 12 out of 30 planned, an analysis was not possible.

Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: One participant was not evaluable for response as participant expired prior to performing restaging evaluation.

Number of participants evaluated using Response to Treatment in Solid Tumors (RECIST) with definitions of Complete Response (CR): disappearance of all target lesions; and, Partial Response: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Maintained Continued CR: participants who entered study in a CR and maintained CR post study treatment. Evaluations once a week till Day +30, then Days 30, 60, and 100 then at 6 months or until disease progression.

Outcome measures

Outcome measures
Measure
Bevacizumab + High-Dose Chemotherapy
n=12 Participants
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m\^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m\^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m\^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
Participant Response
Complete Response (CR)
33.3 percentage of participants
Participant Response
Maintained Continued CR
42.0 percentage of participants
Participant Response
Partial Response (PR)
8.3 percentage of participants
Participant Response
No Response
8.3 percentage of participants
Participant Response
Not Evaluable
8.3 percentage of participants

Adverse Events

Bevacizumab + High-Dose Chemotherapy

Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Bevacizumab + High-Dose Chemotherapy
n=12 participants at risk
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m\^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m\^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m\^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
Infections and infestations
Death
8.3%
1/12 • Number of events 1 • 3 years and six months

Other adverse events

Other adverse events
Measure
Bevacizumab + High-Dose Chemotherapy
n=12 participants at risk
Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m\^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m\^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m\^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
Gastrointestinal disorders
Mucositis
75.0%
9/12 • Number of events 9 • 3 years and six months
Gastrointestinal disorders
Nausea
75.0%
9/12 • Number of events 9 • 3 years and six months
Hepatobiliary disorders
Elevated Bilirubin
16.7%
2/12 • Number of events 2 • 3 years and six months
Infections and infestations
Enterococcus Infection
16.7%
2/12 • Number of events 2 • 3 years and six months
Infections and infestations
Neutropenic Fever
75.0%
9/12 • Number of events 9 • 3 years and six months
Respiratory, thoracic and mediastinal disorders
Pneumonitis
16.7%
2/12 • Number of events 2 • 3 years and six months
Gastrointestinal disorders
Diarrhea
58.3%
7/12 • Number of events 7 • 3 years and six months
Skin and subcutaneous tissue disorders
Skin Rash
66.7%
8/12 • Number of events 8 • 3 years and six months
General disorders
Fever
8.3%
1/12 • Number of events 1 • 3 years and six months
Renal and urinary disorders
Cystitis
8.3%
1/12 • Number of events 1 • 3 years and six months
Cardiac disorders
Hypotension
8.3%
1/12 • Number of events 1 • 3 years and six months
Renal and urinary disorders
Elevated Creatinine
8.3%
1/12 • Number of events 1 • 3 years and six months

Additional Information

Yago Nieto, MD, PhD / Professor

The University of Texas MD Anderson Cancer

Results disclosure agreements

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