Avastin in Combination Wtih Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Malignant Tumor of Peritoneum |
Drug: Avastin Drug: Docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Progression-free Survival (PFS) at 6 Months [ Time Frame: 6 months per participant ] [ Designated as safety issue: No ]Progression-Free Survival (PFS): is the period from study entry until disease progression, death due to disease progression or date of last contact. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions.
- Duration of PFS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Duration of Response: Time in months of stable disease, complete response or partial response to progressive disease. Stable Disease: Any condition not meeting the other RECIST criteria (CR, PR, PD, Symptomatic Deterioration).
Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions is documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125 level, if elevated at baseline.
- Response Rate (RR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum longest diameter (LD). There can be no unequivocal progression of nontarget lesions and no new lesions. Documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured only by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. A PR according to CA-125 levels has occurred if a 50% decrease in the level from the 2 elevated baseline levels, and must be confirmed by a 4th sample at least 28 days after the prior sample OR a 75% serial decrease in CA-125 levels occurs over 3 samples. Final sample must be analyzed at least 28 days after the prior sample.
Symptomatic Deterioration: A global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of PD.
- Incidence of Serious Adverse Events (SAEs) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]The final safety analysis will include all patients who receive at least one dose of any study drug. The incidence of serious adverse experiences (SAEs) treatment related will be summarized by type and severity and exact 95% confidence intervals (CIs) for the rates of such SAEs will be computed.
- Overall Survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]Overall Survival (OS): defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact (regardless of whether or not this contact is on a subsequent protocol). Survival (PFS and OS) will be analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.
| Enrollment: | 45 |
| Study Start Date: | March 2007 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combination Therapy
Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Response assessment every 3 cycles (9 weeks).
|
Drug: Avastin
15 mg/kg, In 100 ml NS IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle
Other Names:
Drug: Docetaxel
40 mg/m^2, In 250 ml D5W or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle
Other Name: TAXOTERE®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 CA 125 criteria (Journal of the National Cancer Institute, 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.
- Women of childbearing potential must have a negative pregnancy test.
- Patients of childbearing potential must be willing to consent to using effective contraception while on treatment and for 3 months following the completion of treatment.
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
- Evidence of bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- Pregnant (positive pregnancy test) or lactating
- Urine protein: creatinine ratio >/= 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Evidence of malignancy in the last 5 years, other than nonmelanoma cutaneous carcinomas
- History of hemoptysis (bright red blood of 1/2 teaspoon or more) within last 3 months
- Patients believed to possibly be at higher than average risk of perforation will be excluded from study. This includes symptoms or findings of partial or complete bowel obstruction, history of fistula, patients requiring parenteral nutrition and hydration, and those with history of prior perforation due to tumor or perforation within last 6 months from other causes.
- Inability to comply with study and/or follow-up procedures.
- Patients who are not on a stable dose of anticoagulation therapy. Patients who are on a stable anticoagulation regimen, including coumadin or low molecular-weight heparin, will not be excluded.
Contacts and Locations| United States, Florida | |
| Broward General Medical Center Cancer Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Women's Cancer Associates | |
| Saint Petersburg, Florida, United States, 33701 | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, North Carolina | |
| Duke Cancer Institute | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Robert M. Wenham, MD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00504257 History of Changes |
| Other Study ID Numbers: | MCC-14920, AVF3823s, IST13070 |
| Study First Received: | July 17, 2007 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
recurrent ovarian epithelial cancer recurrent primary peritoneal cavity cancer recurrent fallopian tube cancer |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Docetaxel Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013