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Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma

A Phase II Trial of Avastin in Combination With Docetaxel in Patients With Recurrence of Epithelial Carcinoma of the Ovary/Fallopian Tube/Peritoneum Within 12 Months of Platinum Therapy

NCT00504257•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effectiveness of the combination of Avastin and Docetaxel in the treatment of women with platinum sensitive recurrent epithelial ovarian cancer within 12 months of platinum chemotherapy.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Signed informed consent
•Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or fallopian tube cancer
•Patient's disease recurrence or progression occurs between 0 to 12 months (1 to 365 days) from prior platinum-containing chemotherapy regimen. Patients, however, may not receive study drug until at least 28 days from prior chemotherapy.
•The patient may have received up to three prior chemotherapy regimens for the treatment of this malignancy. Patients who may have received prior treatment with paclitaxel and/or a platinum compound will be allowed. Rechallenge with the same platinum based regimen is considered 1 prior regimen. Patients who have been treated with consolidation treatment are allowed and the consolidation will not be considered a separate regimen. Hormonal therapy (i.e. progesterones, estrogens, anti-estrogens, aromatase inhibitors) will not be considered a prior chemotherapy regimen.
•Measurable or evaluable disease either by the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) or cancer antigen (CA)125 criteria \[Journal of the National Cancer Institute (JNCI), Vol. 96, No. 6, March 17, 2004, Vergote JNCI 2000\]
•At least 4 weeks since major surgery, with full recovery
•At least 3 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside of the radiation port.
•Eastern Cooperative Oncology Group (ECOG) performance status \</= 2
•Hematologic (minimal values): Absolute neutrophil count \>/= 1,500/mm\^3, Hemoglobin \>/= 8.0 g/dL (transfusions allowed), Platelet count \>/= 100,000/mm\^3
•Hepatic: Total Bilirubin \</= upper limit of normal (ULN), alanine transaminase (AST) and alanine transaminase (ALT) and alkaline phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used.
+2 more criteria

Exclusion Criteria

•Prior treatment with Docetaxel or Avastin
•Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for the ovarian cancer. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to enrollment in order for the patient to be eligible to participate in this trial. Continuation of hormonal replacement therapy is allowed.
•Peripheral neuropathy \>/= grade 2
•History of a severe hypersensitivity reaction to Docetaxel, Avastin, or to other drugs formulated with polysorbate (Tween) 80.
•Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study of Avastin
•Blood pressure of \>150/100 mmHg Unstable angina
•New York Heart Association (NYHA) Grade II or greater congestive heart failure
•History of myocardial infarction within 6 months prior to Day 1
•History of stroke within 6 months prior to Day 1
•Clinically significant peripheral vascular disease
+13 more criteria

Locations (4)

Broward General Medical Center Cancer Center

Fort Lauderdale, Florida, United States

Women's Cancer Associates

St. Petersburg, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Duke Cancer Institute

Durham, North Carolina, United States

Key Dates

Start Date

March 1, 2007

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

February 6, 2014

Enrollment

ACTUAL participants

Conditions

Fallopian Tube CancerOvarian CancerMalignant Tumor of Peritoneum

Interventions

Avastin

DRUG

Docetaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma

Inclusion Criteria

Exclusion Criteria

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