First-Line Treatment of Bevacizumab, Carboplatin, and Paclitaxel in Treating Participants With Stage III-IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
A Phase II Trial of Bevacizumab With Carboplatin and Weekly Paclitaxel as First-Line Treatment in Epithelial Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma
2 other identifiers
interventional
33
1 country
5
Brief Summary
This phase II trial studies how well first-line treatment of bevacizumab, carboplatin, and paclitaxel work in treating participants with stage III- IV ovarian, primary peritoneal and fallopian tube cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bevacizumab, carboplatin, and paclitaxel as first-line treatment may work better at treating ovarian, primary peritoneal, and fallopian tube cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2010
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2010
CompletedFirst Posted
Study publicly available on registry
April 2, 2010
CompletedStudy Start
First participant enrolled
April 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2021
CompletedResults Posted
Study results publicly available
June 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2022
CompletedOctober 28, 2022
September 1, 2022
11.7 years
March 31, 2010
December 17, 2021
September 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Success
Participants with newly diagnosed ovarian, primary peritoneal, and fallopian tube cancers treated with bevacizumab, carboplatin, and weekly paclitaxel that can tolerate at least 4 cycles of therapy regardless of delay or dose modification.
Up to 2 years
Secondary Outcomes (1)
Progression-free Survival of Optimal (RO) </= 1cm (PFS) vs Suboptimal > 1 cm
2 years
Study Arms (1)
Treatment (paclitaxel, carboplatin, bevacizumab)
EXPERIMENTALParticipants receive paclitaxel IV over 3 hours on days 1, 8 and 15 and carboplatin IV over 1 hour on day 1. Beginning course 2, participants also receive bevacizumab IV over 1.5 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer; FIGO stage III and IV defined surgically at the completion of initial abdominal surgery 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, as well as a maximal effort at tumor debulking.
- (continued from no. 1) Those patients with stage III cancer in which the largest maximal diameter of any residual tumor implant at the completion of this initial surgery is no greater than 1 cm will be defined as optimal; all others will be defined as suboptimal.
- The histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma. Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, Endometrioid adenocarcinoma, Mucinous adenocarcinoma, Undifferentiated carcinoma, Clear cell adenocarcinoma, Mixed epithelial carcinoma, Transitional cell, Malignant Brenner's Tumor, Adenocarcinoma N.O.S. 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.
- Patients must be entered no later than 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction.
- Patients with measurable and non-measurable disease are eligible. Patients may or may not have cancer-related symptoms.
- Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not progestins for management of anorexia while on protocol directed therapy.
- Patients with an ECOG Performance Status of 0, 1, or 2.
- Patients must have normal organ and marrow function as defined below: leukocytes \>3,000/mcL; absolute neutrophil count \>1,500/mcL; platelets \>100,000/mcL; total bilirubin \<1.5 X institutional upper limits of normal; AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal; Alkaline phosphatase (AP) \<2.5 X institutional upper limit of normal; creatinine \<1.5X institutional upper limit of normal OR creatinine clearance \>50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Ability to understand and the willingness to sign a written informed consent document.
You may not qualify if:
- Patients with 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 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.
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
- Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian or peritoneal primary cancer.
- Patients who are currently participating or planning to participate in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study or who are receiving other investigational agents.
- 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 IB; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions.
- With the exception of superficial basal cell and superficial squamous (skin) cell, carcinoma in situ of the cervix and other specific malignancies as noted above, 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 are excluded.
- Patients with acute hepatitis or active infection that requires parenteral antibiotics.
- Patients with serious non-healing wound, ulcer, or untreated bone fracture. This includes a history of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1. Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations until closure.
- Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy (in the absence of therapeutic anticoagulation), or tumor involving major vessels.
- History of hemoptysis (\>/=1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1.
- Patients 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.
- Patients with clinically significant cardiovascular disease. This includes: 1) Uncontrolled hypertension, defined as systolic \> 140 mm Hg or diastolic \> 90 mm Hg; 2) Myocardial infarction or unstable angina \< 6 months prior to registration; 3) New York Heart Association (NYHA) Grade II or greater congestive heart failure; 4) Serious cardiac arrhythmia requiring medication. This does not include asymptomatic, atrial fibrillation with controlled ventricular rate
- (continued from no. 13) CTCAE Grade 2 or greater peripheral vascular disease (at least brief (\<24 hrs) episodes of ischemia managed non-surgically and without permanent deficit); Prior history of hypertensive crisis or hypertensive encephalopathy; Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (5)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson Regional Care Center-Katy
Houston, Texas, 77094, United States
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, 77058, United States
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, 77478, United States
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, 77384, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Anil K. Sood, MD/Professor, Gyn Onc & Reproductive Med
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Anil Sood
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2010
First Posted
April 2, 2010
Study Start
April 14, 2010
Primary Completion
December 7, 2021
Study Completion
September 13, 2022
Last Updated
October 28, 2022
Results First Posted
June 10, 2022
Record last verified: 2022-09