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A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865, IND #113912) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865, IND #113912)

Phase 3
18 Years
Open (Enrolling)
Brenner Tumor, Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Thank you

Trial Information

A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865, IND #113912) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865, IND #113912)


I. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy
increases the duration of overall survival in patients with recurrent platinum sensitive
epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.

II. To determine if the addition of bevacizumab to the second-line and maintenance phases of
treatment increases the duration of overall survival relative to second-line paclitaxel and
carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer,
peritoneal primary or fallopian tube cancer.


I. To determine if the addition of bevacizumab to the second-line and maintenance phase of
treatment increases the duration of progression-free survival relative to second-line
paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial
ovarian cancer, peritoneal primary or Fallopian tube cancer.

II. To prospectively determine the incidence of carboplatin and paclitaxel hypersensitivity
in these patients undergoing retreatment with both agents as first recurrence therapy.

III. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy
increases quality of life (QOL) of patients with recurrent platinum-sensitive ovarian
epithelial cancer or primary peritoneal cavity cancer, as measured by the FACT-O trial
outcome index and Rand SF-36 physical functioning scale.

IV. To determine if the addition of bevacizumab to the second-line and maintenance phases of
treatment increases QOL relative to second-line paclitaxel and carboplatin alone in patients
with recurrent platinum-sensitive ovarian epithelial cancer or primary peritoneal cavity

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 4 treatment groups.
Patients who are not candidates for surgical cytoreduction (i.e., those for whom complete
cytoreduction in the estimation of the investigator is impossible or a medical infirmity
precludes exploration and debulking) are eligible to receive chemotherapy after

Patients who are eligible for surgery undergo abdominal exploration with cytoreduction and
undergo tumor tissue collection and complete a quality of life questionnaire before and
after surgery. All patients are then randomized to 1 of 4 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours or docetaxel IV over 1
hour and carboplatin IV over 60 minutes on day 1.

ARM II: Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on
day 1.

ARM III: Patients receive gemcitabine IV over 60 minutes on days 1and 8 and carboplatin as
in arm I.

ARM IV: Patients receive gemcitabine IV as in arm III, bevacizumab IV and carboplatin IV as
in arm II.

In all arms, treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity.

Patients with measurable disease achieving a clinical response (CR) receive 6-8 courses of
therapy. Patients with stable disease or partial regression receive a maximum of 6 courses.

Patients without measurable lesions as determined by a computed tomography (CT) scan prior
to initiating study treatment continue therapy for 6 courses or, if CA-125 normalizes, for 2
cycles beyond CA-125 normalization, whichever is greater. Patients in arm II then receive a
maintenance regimen comprising bevacizumab IV over 30-90 minutes. Treatment with bevacizumab
alone repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 10 years.

Inclusion Criteria:

- Patients must have histologic diagnosis of ovarian epithelial carcinoma, peritoneal
primary or fallopian tube carcinoma, which is now recurrent

- The following histologic epithelial cell types are eligible:

- Serous adenocarcinoma

- Endometrioid adenocarcinoma

- Mucinous adenocarcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Mixed epithelial carcinoma

- Transitional cell carcinoma

- Malignant Brenner Tumor

- Adenocarcinoma not otherwise specified

- Patients must have had a complete response to front-line platinum-taxane therapy (at
least 3 cycles) and a treatment-free interval without clinical evidence of
progressive disease lasting at least 6 months

- A complete response to front-line chemotherapy must include the following:

- Negative physical exam

- Negative pelvic exam

- Normalization of CA125, if elevated at baseline

- Negative radiographic assessment of disease

- All patients must have also had a treatment-free interval without clinical
evidence of progressive disease of at least 6 months from completion of
front-line chemotherapy (both platinum and taxane); front-line therapy may have
included a biologic agent

- Front-line treatment may include maintenance therapy following complete clinical
or pathological response; however, maintenance cytotoxic chemotherapy must be
discontinued for a minimum of 6 months prior to documentation of recurrent
disease; patients receiving maintenance biological therapy or hormonal therapy
are ELIGIBLE provided their recurrence is documented more than 6 months from
primary cytotoxic chemotherapy completion (includes maintenance chemotherapy)
AND a minimum 4 weeks has elapsed since their last infusion of biological

- Patients must have clinically evident recurrent disease for the purpose of this

- Measurable disease (RECIST) is defined as at least one lesion that can be
accurately measured in at least one dimension (longest dimension to be
recorded); each lesion must be more than or equal to 20 mm when measured by
conventional techniques, MRI or CT, or more than or equal to 10 mm when measured
by spiral CT

- Absolute neutrophil count (ANC) >= 1,500/mm^3 equivalent to Common Toxicity Criteria
for Adverse Events v3.0 (CTCAE) Grade1

- Platelet count >= 100,000/mm^3 (CTCAE Grade 0-1)

- Creatinine (non-isotope dilution mass spectrometry [IDMS]) =< 1.5 times upper limit
of normal (ULN)

- Total bilirubin =< 1.5 times ULN

- Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) =<
2.5 times ULN (< 5.0 times ULN in the presence of liver metastasis)

- Alkaline phosphatase =< 2.5 times ULN (< 5.0 times ULN in the presence of liver

- Patients must have a urine protein-to-creatinine ratio (UPCR) < 1.0 mg/dL

- Patients who are not candidates for surgical cytoreduction are eligible for the
chemotherapy randomization; patients are not considered candidates for surgical
cytoreduction if complete cytoreduction in the estimation of the investigator is
impossible or a medical infirmity precludes exploration and debulking

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information

- Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

Exclusion Criteria:

- Patients who have more than one previous regimen of chemotherapy (maintenance therapy
is not considered a second regimen)

- Patients receiving concurrent immunotherapy, or radiotherapy

- Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded

- Patients whom have already undergone secondary cytoreduction for recurrent disease
are excluded

- Patients with a prior histologic diagnosis of borderline, low malignant potential
(grade 0) epithelial carcinoma that was surgically resected and who subsequently
developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer
are eligible provided they meet the inclusion criteria above

- Patients who require parenteral hydration or nutrition and have evidence of partial
bowel obstruction or perforation

- Patients 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;

- No more than superficial myometrial invasion, without vascular or lymphatic

- No poorly differentiated subtypes, including papillary serous, clear cell or
other International Federation of Gynecology and Obstetrics (FIGO) Grade 3

- Patients with uncontrolled infection

- Patients with concurrent severe medical problems unrelated to the malignancy that
would significantly limit full compliance with the study or expose the patient to
extreme risk or decreased life expectancy

- Patients with peripheral neuropathy >= grade 2

- Patients with a history of allergic reactions to carboplatin and/or paclitaxel or
chemically similar compounds; patients with allergic (hypersensitivity) reactions to
these chemotherapeutic agents are NOT excluded IF they were successfully retreated
following a desensitization program or protocol

- Patients with known hypersensitivity to Chinese hamster ovary cell products or other
recombinant human or humanized antibodies

- Patients of childbearing potential, not practicing adequate contraception, patients
who are pregnant or patients who are nursing are not eligible for this trial; to
date, no fetal studies in animal or humans have been performed; the possibility of
harm to a fetus is likely; bevacizumab specifically inhibits VEGF, which is
responsible for the formation of new blood vessels during development, and antibodies
can cross the placenta; therefore, bevacizumab should not be administered to pregnant
women; in addition, there are unknown immediate and long-term consequences of
chemotherapy administration to these women; in addition, surgical exploration as
mandated by randomization during pregnancy may cause imminent mortal consequences;
further, it is not known whether bevacizumab is excreted in human milk; because many
drugs are excreted in human milk, bevacizumab should not be administered to nursing
women; subjects will be apprised of the large potential risk to a developing fetus

- Patients with other invasive malignancies, with the exception of nonmelanoma skin
cancer, or patients who had (or have) any evidence of the other cancer present within
the past 5 years or whose previous cancer treatment contraindicates this protocol

- Patients with active bleeding or pathologic conditions that carry high risk of
bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major

- Patients with a history or evidence upon physical examination of central nervous
system (CNS) disease, including primary brain tumor, seizures not controlled with
standard medical therapy, any brain metastases, or a history of stroke within the
past 5 years of the first date of treatment on this study

- Patients with clinically significant cardiovascular disease including any of the

- Significant cardiac conduction abnormalities (e.g., PR interval > 0.24 sec or
2nd or 3rd degree atrioventricular [AV] block )

- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg
or diastolic BP > 90 mm Hg

- Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6

- New York Heart Association (NYHA) grade II or greater congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Grade II or greater peripheral vascular disease except episodes of ischemia <
24 hrs in duration that are managed non-surgically and without permanent deficit

- History of cerebrovascular accident (CVA) within the past 6 months

- Patients who have had a major surgical procedure, open biopsy, dental extractions or
other dental surgery/procedure that results in an open wound, or significant
traumatic injury within 28 days prior to the first date of treatment on this study,
or anticipation of need for major surgical procedure during the course of the study;
patients with placement of vascular access device or core biopsy within 7 days prior
to the first date of treatment on this study:

- Patients undergoing pre-treatment secondary cytoreduction will undergo therapy
with bevacizumab on cycle 2

- Patients undergoing pre-treatment surgery for purposes other than cytoreduction
may also participate provided they meet eligibility; patients randomized to arms
containing bevacizumab must wait a minimum of 28 days since that procedure to
begin protocol treatment; patients who undergo an uncomplicated port placement
must wait a minimum of 7 days to begin protocol treatment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Up to 10 years

Safety Issue:


Principal Investigator

Robert Coleman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

Related Keywords:

  • Brenner Tumor
  • Fallopian Tube Cancer
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Brenner Tumor
  • Carcinoma
  • Cystadenocarcinoma
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Carcinoma, Endometrioid
  • Cystadenocarcinoma, Mucinous
  • Cystadenocarcinoma, Serous
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



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Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center-Mishawaka Mishawaka, Indiana  46545-1470
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Bronson Battle Creek Battle Creek, Michigan  49017
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio  44111
Women's Cancer Care Associates LLC Albany, New York  12208
Fletcher Allen Health Care-Medical Center Burlington, Vermont  05401
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370