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Study Summary
No. 2007-0368:.......Ovary......Yago Nieto......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2007-0368
Study Title:Bevacizumab Combined With High-Dose Chemotherapy in Patients With Relapsed Ovarian Cancer
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Physician New Patient Referral
Name:Yago NietoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
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General Information
Disease Group:OvarySupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Weekly during the first month, at D+100 and 6 month. Further evaluations can be
done by primary care provider.
Treatment
Agents:
Bevacizumab
Carboplatin
Cyclophosphamide
Docetaxel
Gemcitabine
Melphalan
Topotecan
Home Care:No home treatment required
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
One 4-week admission
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Primary Endpoint
To derive estimates of the therapeutic impact produced by the new treatment, by analyzing the event-free survival (EFS).

Secondary Endpoints:
1. To estimate the response rate (RR), and complete response (CR) rate and overall survival (OS) among patients with measurable disease
2. To Describe the side effect profile of Bevacizumab/Gemcitabine/Docetaxel/Melphalan/Carboplatin (Bev/DMC) and Bevacizumab/Topotecan/Melphalan/Cyclophosphamide (Bev/TMC):
- Extramedullary side effects
- Engraftment rate.
3. To derive estimates of the overall survival (OS)
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Study Status Information
Study Activation / Registration Date:12/19/2007
IRB Review and Approval Date:12/19/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Age 18 - <70.

2) Patients with advanced ovarian, fallopian or primary peritoneal cancer in second or later complete remission, or untreated or refractory relapse, defined as relapse within 6 months of prior platinum treatment or lack of response to salvage treatment.

3) No evidence of small bowel obstruction, as determined by CT scan of the abdomen and pelvis with oral and rectal contrast, within 30 days before the initiation of study treatment.

4) Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >=60 ml/min, and urinary protein excretion <=500 mg/day.

5) Adequate hepatic function, as defined by SGOT and SGPT <=3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <=2 x ULN or considered not clinically significant.

6) Adequate pulmonary function with FEV1, FVC and DLCO >=50% of predicted, corrected for volume or hemoglobin.

7) Adequate cardiac function with left ventricular ejection fraction >=45%. No uncontrolled arrhythmias or symptomatic cardiac disease.

8) Zubrod performance status <2.

Exclusion Criteria:1) Failure to collect more than 3 x 10e6 CD34+ stem cells/kg body weight

2) Patients with unresolved grade 3 or greater non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI.

3) Major surgery within 30 days before the initiation of study treatment

4) Radiotherapy within 21 days prior to initiation of study treatment

5) Patients with active CNS disease.

6) Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Principal Investigator and consider liver biopsy.

7) Uncontrolled infection, including HIV or HTLV-1 infection.

8) Aspirin (> 325 mg/day) use within 10 days before initiation of study treatment.

9) Ongoing uncontrolled hypertension (>140/90 mm Hg on medication).

10) Non-healing wound or significant traumatic injury within 30 days before the initiation of study treatment

11) Previous autologous or allogeneic stem cell transplant during the past year.

12) Positive Beta HCG test in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.

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Links
Registration Number: NCT00583622
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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