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A Pilot Phase II Study Evaluating the Combination of Oxaliplatin and Docetaxel With Bevacizumab as First Line Therapy in Patients With FIGO Stage IB-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Pilot Phase II Study Evaluating the Combination of Oxaliplatin and Docetaxel With Bevacizumab as First Line Therapy in Patients With FIGO Stage IB-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma

Participants were

- administered study medication approximately 28 days after initial surgery for ovarian

- received the study treatment regimen of up to one year unless there was disease
progression, unacceptable toxicity, death, participant refusal, or treatment delay
beyond the time frame permitted for each treatment

Participants were followed for survival for a minimum 3 years from the date of enrollment

Inclusion Criteria


1. Females 18 years of age or older

2. Participants with a histologic diagnosis of ovarian, primary peritoneal, or fallopian
tube carcinoma, Stage Ib- IV, with either optimal (≤ 1 cm residual disease) or
suboptimal residual disease ( > 1 cm maximal diameter any remaining lesion) following
initial surgery.

3. Participants with the following histologic epithelial cell types are eligible:
Serious adenocarcinoma, endometrioid adenocarcinoma, mucinous
adenocarcinoma,undifferentiated carcinoma, clear cell adenocarcinoma, mixed
epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or
adenocarcinoma N.O.S.

4. Participant must have adequate bone marrow function

5. Participant must have adequate renal function

6. Participant must have adequate urine protein/creatinine reaction (UPC) of <1.0;

7. Participant must have adequate neurologic function

8. Hepatic function: Total Bilirubin ≤ ULN; AST and ALT and Alkaline Phosphatase must be
within the range allowing for eligibility. In determining eligibility the more
abnormal of the two values (AST or ALT) should be used.

9. Blood Coagulation parameters: PT such that international normalized ratio (INR) is <
1.5 (or an in-range INR, usually between 2 and 3, if a participant is on stable dose
of therapeutic Warfarin or low molecular weight heparin) and a PTT < 1.2 times the
upper limit normal.

10. Participants must be enrolled in the study prior to 50 days (every effort will be
made for prior to 28 days) after initial surgery performed for the combined purpose
of diagnosis, staging and cytoreduction.

11. Participants with measurable and non-measurable disease are eligible. Participants
with suboptimal disease are eligible. Participants may or may not have
cancer-related symptoms.

12. Participants who have met the pre-entry requirements specified including serologic
measurement of CA-125 as a baseline for subsequent determination of response using
Rustin criteria.

13. Participants with a GOG Performance Status of 0, 1, or 2.


1. Participants with a current diagnosis of epithelial ovarian tumor of low malignant
potential (Borderline carcinomas) are not eligible. Participants with a prior
diagnosis of a low malignant potential tumor that was surgically resected and who
subsequently develop invasive adenocarcinoma are eligible, provided that they have
not received prior chemotherapy for any ovarian tumor.

2. Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or
carcinosarcomas, metastatic carcinomas from other sites to the ovary and low
malignant potential tumors including so called micropapillary serous carcinomas are
not eligible.

3. Participants who have received prior radiotherapy to any portion of the abdominal
cavity or pelvis are excluded. Prior radiation for localized cancer of the skin is
permitted, provided that it was completed more than 5 years prior to enrollment, and
the participant remains free of recurrent or metastatic disease.

4. Participants who have received any prior anticancer chemotherapy or biologic therapy
for any malignancy are excluded.

5. Participants with synchronous primary endometrial cancer, or a past history of
primary endometrial cancer, are excluded, unless all of the following conditions are
met: Stage not greater than I-B; Less than 3 mm invasion without vascular or
lymphatic invasion; No poorly differentiated subtypes, including papillary serous,
clear cell, or other FIGO Grade 3 lesions.

6. Participants with any history of cancer, with the exception of inclusion criteria #2
and #3, and non-melanoma skin cancer, who are cancer free for the last 5 years, are

7. Participant with acute hepatitis or active infection that requires parenteral

8. Participants with serious, non-healing wound, ulcer, or bone fracture. This includes
history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 28 days.

Participants with granulating incisions healing by secondary intention with no
evidence of fascial dehiscence or infection are eligible but require weekly wound

9. Participants with active bleeding or pathologic conditions that carry high risk of
bleeding,such as known bleeding disorder, coagulopathy, or tumor involving major

10. Participants with history or evidence upon physical examination of CNS disease,
including primary brain tumor, seizures not controlled with standard medical therapy,
any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient
ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date
of treatment on this study.

11. Participants with clinically significant cardiovascular disease.

12. Participants with clinically significant proteinuria. Urine protein should be
screened by urinalysis. Participants discovered to have a urine protein: serum
creatinine ratio greater than or equal to 1 should undergo a 24-hour urine
collection, which must be an adequate collection and must demonstrate < 1000 mg
protein/24 hr to allow participation in the study.

13. Participants with or with anticipation of invasive procedures.

14. Participants with GOG Performance Grade of 3 or 4.

15. Participants who are pregnant or nursing.

16. Participants with known hypersensitivity to Chinese hamster ovary cell products or
other recombinant human or humanized antibodies and hypersensitivity to polysorbate
80 or hypersensitivity to any of the study drugs and its ingredients.

17. Participants who participated in a study with any investigational product/device
within the last 30 days.

18. Any medical condition that in the judgment of the investigator would jeopardize any
participant safety or the study drug evaluation for efficacy and safety.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Twelve-month Progression-free Survival (PFS) Rate in Participants

Outcome Description:

Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: appearance of a new lesion symptomatic deterioration progression of target or nontarget lesions death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS.

Outcome Time Frame:

up to 12 months following treatment initiation

Safety Issue:


Principal Investigator

Phyllis Diener, BS, MT (ASCP)

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

August 2011

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms



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