GOG-0262: A Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination With Carboplatin With or Without Concurrent and Consolidation Bevacizumab (NSC #704865, IND #113912) in the Treatment of Primary Stage II, III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer and ACRIN 6695: Perfusion CT Imaging to Evaluate Treatment Response in Patients Participating in GOG-0262

Inclusion Criteria:

- Patients must have measurable disease; at least one target lesion must have a minimum
length of 1 cm in both the long and short axis (determined at the local site); for
primary surgery patients, if no radiographic evidence of measurable disease is
obtained prior to registration this can be based on surgical findings; imaging then
would need to be completed in the 14 days between Gynecology Oncology Group (GOG)
registration and chemotherapy initiation

- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube
cancer

- Stage II -IV suboptimally debulked (any residual disease > 1 cm); International
Federation of Gynecology and Obstetrics (FIGO) stage is assessed following the
completion of initial abdominal surgery, appropriate imaging studies and with
appropriate tissue available for histologic evaluation; the minimum surgery
required is an abdominal surgery providing tissue for histologic evaluation and
establishing and documenting the primary site and stage; if additional surgery
was performed, it should have been in accordance with appropriate surgery for
ovarian or peritoneal carcinoma described in the GOG Surgical Procedures Manual

- The following histologic epithelial cell types are eligible:

- Serous

- Endometrioid

- Clear cell

- Mucinous adenocarcinoma

- Undifferentiated carcinoma

- Mixed epithelial carcinoma

- Transitional cell carcinoma

- Malignant Brenner tumor

- Adenocarcinoma not otherwise specified

- Histologic features of the tumor must be compatible with a primary Müllerian
epithelial adenocarcinoma; patients may have co-existing fallopian tube carcinoma
in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or
fallopian tube; of note, patients with clear cell and mucinous tumors will be
eligible unless there is a higher priority protocol

- For patients undergoing neoadjuvant chemotherapy (NAC) with interval cytoreductive
surgery (ICS), a core tissue (not fine needle aspiration) biopsy is required; the
tissue must be consistent with a müllerian origin; patients will require
documentation of at least stage II or extraovarian sites of disease acquired via
imaging or surgery (without attempt at cytoreduction)

- Patients will not be eligible for therapy on other clinical trials evaluating
consolidation or maintenance therapy

- Absolute neutrophil count (ANC) >= 1,500/mm^3 (not induced or supported by
granulocyte colony-stimulating factors)

- Platelet count >= 100,000/mm^3

- Creatinine =< 1.5 times upper limit of normal (ULN)

- Bilirubin =< 1.5 times ULN

- Serum glutamic oxalo-acetic transaminase (SGOT) =< 3 times ULN

- Alkaline phosphatase =< 2.5 times ULN

- Neuropathy (sensory or motor) >= Common Terminology Criteria for Adverse Events
(CTCAE) grade 1

- GOG performance status 0-2

- Patients must be entered within 12 weeks of diagnostic/staging surgery

- An approved informed consent and authorization permitting release of personal health
information and must be signed by the patient or guardian

- Patients who elect to receive bevacizumab must meet the following criteria:

- Patients in this trial may receive ovarian estrogen and/or progestin replacement
therapy as indicated at the lowest effective dose(s) for control of menopausal
symptoms at any time, but not high-dose progestins for management of anorexia
while on protocol-directed therapy or prior to disease progression due to
thrombophlebitis risk

- Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5
(or an in-range INR, usually between 2 and 3, if a patient is on a stable dose
of therapeutic warfarin for management of venous thrombosis including pulmonary
thromboembolus)

- Heparin, lovenox or alternative anticoagulants are acceptable

- Partial prothrombin time (PTT) < 1.2 times ULN

- American College of Radiology Imaging Network (ACRIN) 6695 imaging study:

- Patients enrolled after February 8, 2012 must participate in the ACRIN 6695
component at ACRIN-qualified institutions

- At least one target lesion must have a minimum length of 1 cm in both the long
and short axis (as determined by the local site), at least half of the target
lesion must have attenuation greater than or equal to 10 Hounsfield Units (HU)
on the unenhanced (computed tomography (CT), and at least half of the lesion
must have maximum enhancement greater than or equal to 5 HU in the perfusion CT
scan (as determined by the American College of Radiology [ACR] Imaging Core Lab)

Exclusion Criteria:

- Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly
"tumors of low malignant potential") or recurrent invasive epithelial ovarian,
primary peritoneal or fallopian tube cancer treated with surgery only (such as
patients with stage I-A or I-B low grade epithelial ovarian or fallopian tube
cancers) are not eligible; patients with a prior diagnosis of a borderline tumor that
was surgically resected and who subsequently develop an unrelated, new invasive
epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible,
provided that they have not received prior chemotherapy for any ovarian tumor

- Synchronous primary endometrial cancer or a history of primary endometrial cancer,
unless all of the following conditions are met:

- Stage not greater than Ia

- Grade 1 or 2

- No more than superficial myometrial invasion

- No vascular or lymphatic invasion

- No poorly differentiated subtypes, including papillary serous, clear cell, or
other FIGO grade 3 lesions

- Prior radiotherapy to any portion of the abdominal cavity or pelvis

- Prior radiotherapy for localized cancer of the breast, head and neck, or skin is
allowed provided that it was completed > 3 years ago and that the patient
remains free of recurrent or metastatic disease

- Prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvant
chemotherapy for ovarian, primary peritoneal, or fallopian tube cancer

- Prior adjuvant chemotherapy for localized breast cancer allowed provided that it
was completed > 3 years ago and that the patient remains free of recurrent or
metastatic disease

- Prior targeted therapy (including, but not limited to, vaccines, antibodies, tyrosine
kinase inhibitors) or hormonal therapy for management of ovarian epithelial,
fallopian tube, or primary peritoneal cancer

- Prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including
bevacizumab

- Acute hepatitis or active infection that requires parenteral antibiotics

- Patients who are pregnant or nursing

- Patients of childbearing potential must agree to use contraceptive measures during
study therapy and for at least six months after completion of bevacizumab therapy

- With the exception of non-melanoma skin cancer, patients with other invasive
malignancies who had (or have) any evidence of the other cancer present within the
last five years or whose previous cancer treatment contraindicates this protocol
therapy

- Clinically significant cardiovascular disease, including:

- Myocardial infarction or unstable angina within the past 6 months

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

- Serious cardiac arrhythmia requiring medication (this does not include
asymptomatic, atrial fibrillation with controlled ventricular rate)

- Patients with medical history or conditions not otherwise previously specified which
in the opinion of the investigator should exclude participation in this study

- Patients with known allergy to cremophor or polysorbate 80

- Exclusions for patients who elect to receive bevacizumab:

- * Patients with serious non-healing wound, ulcer, or bone fracture; this includes
history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 28 days; patients with granulating incisions healing by secondary intention
with no evidence of fascial dehiscence or infection are eligible but require weekly
wound examinations

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

- * Patients with 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 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

- Patients with CTCAE Grade 2 or greater peripheral vascular disease [at least
brief (< 24 hours) episodes of ischemia managed non-surgically and without
permanent deficit]

- Patients with a history of CVA within six months

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

- * Patients with clinically significant proteinuria; patients must have a urine
protein-creatinine ratio (UPCR) < 1.0 to allow participation in the study

- * Patients with or with anticipation of invasive procedures as defined below:

- Major surgical procedure, open biopsy or significant traumatic injury within 28
days prior to the first date of bevacizumab therapy (cycle 2)

- Major surgical procedure anticipated during the course of the study; this
includes, but is not limited to, abdominal surgery (laparotomy or laparoscopy)
prior to disease progression, such as colostomy or enterostomy reversal,
secondary cytoreductive surgery, or second look surgery

- Any tissue biopsy, such as a core biopsy, within 7 days prior to the first date
of bevacizumab therapy (cycle 2)

- * Patients with clinical symptoms or signs of gastrointestinal obstruction AND who
require parenteral hydration and/or nutrition

- * Patients with metastatic tumor in the parenchyma of the liver or lungs with
proximity to large vessels which could make the patients at high risk of lethal
hemorrhage during treatment with bevacizumab (ie. hemoptysis, liver rupture)

- ACRIN 6695 exclusions:

- Patients with contraindication to iodinated contrast for perfusion CT imaging

- Patients who receive metformin within 48 hours before perfusion CT imaging