A Randomized Phase II Trial of Avastin (A) or Avastin and Erlotinib (AE) as First Line Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Newly Diagnosed Advanced Ovarian, Fallopian Tube and Primary Peritoneal Cancer & Papillary Serous Mullerian Tumors
18 Years
N/A
Female
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Papillary Serous Mullerian Cancer
Trial Information
A Randomized Phase II Trial of Avastin (A) or Avastin and Erlotinib (AE) as First Line Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Newly Diagnosed Advanced Ovarian, Fallopian Tube and Primary Peritoneal Cancer & Papillary Serous Mullerian Tumors
- Each treatment cycle lasts three weeks (21 days). Participants will receive only
paclitaxel and carboplatin on Day 1 of Cycle 1. They will receive paclitaxel,
carboplatin and Avastin for cycles 2-6. All of these drugs are given intravenously.
- After participants receive six cycles of treatment with paclitaxel and carboplatin,
they will be randomized into one of two study groups. Group 1 will receive treatment
with Avastin every 3 weeks for 1 year. Group 2 will receive Avastin every 3 weeks for
1 year and take erlotinib orally every day for 1 year. This second part will occur
about one month after the second look surgery (see below).
- If there is no cancer seen on a scan that is performed after 6 cycles of paclitaxel,
carboplatin and Avastin, second look surgery will be discussed. The second look
surgery is to see if there is any cancer at the end of treatment that was not seen by
CT scan or MRI. This surgery will take place about one month after the 6th cycle of
treatment if it is recommended.
- During all treatment cycles participants will have a physical exam and be asked
questions about their general health and specific questions about any problems they are
experiencing.
- Blood tests including chemistry, hematology, CA-125, as well as other tests to measure
any additional effect of the study drug or disease status, will be done prior to each
cycle of treatment and during the follow-up period.
- Assessment of the tumor by CT scan or MRI will be done as follows: After every three
cycles of chemotherapy; every three months during consolidation treatment (treatment
with Avastin OR Avastin and erlotinib); every three months after the end of study
treatment for 1 year, unless the tumor grows.
Inclusion Criteria:
- 18 years of age and older
- Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer,
primary peritoneal carcinoma, or papillary serous mullerian carcinoma
- Previous attempted surgical debulking
- Stage III or IV
- Willing and able to undergo second look laparoscopy
- Performance status 0-1 by ECOG scale
- Peripheral neuropathy < grade 2
- Life expectancy of 6 months or greater
Exclusion Criteria:
- Patients with clinically significant cardiovascular disease as outlined in the
protocol
- Neutrophil count < 1,500/mm3; platelet count <100,000/m3
- Alkaline phosphatase or bilirubin > 1.5 x ULN, SGOT > 5 x ULN
- Calculated creatinine clearance < 50ml/min
- Prior chemotherapy or radiotherapy for other malignancy except for the treatment for
localized breast cancer greater than five years prior to diagnosis
- No more than one cycle of first line chemotherapy with carboplatin and paclitaxel
- Inadequate surgical cytoreduction such that interval cytoreductive surgery could
materially improve prognosis
- Concurrent invasive malignancy
- Evidence of bleeding diathesis or coagulopathy
- Evidence of tumor involving major blood vessels on any prior CT scans
- Surgical wound that has failed to close
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, or anticipation of need for major surgical procedure during the
course of this study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to study enrollment
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to day 0
- Serious non-healing wound, ulcer, or bone fracture
- Prior treatment with an anti-angiogenic agent
- Any active bleeding
- Active psychiatric disease or neurologic symptoms requiring treatment
- Presence of central nervous system brain metastases
- Proteinuria at screening as demonstrated by criteria in protocol
- Dementia or significantly altered mental status that would prohibit the understanding
and/or giving of informed consent
- Known hypersensitivity to Cremophor EL or any component of Avastin
- Active bacterial, viral, or fungal infections
- Receiving any other investigational agent
- History of gastrointestinal perforation
- Prior therapies targeting the epidermal growth factor receptor
- Symptoms of bowel obstruction
- Dependence on TPN or IV hydration
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To examine the progression free survival of Avastin and erlotinib (AE) or Avastin (A) as consolidation therapy at predefined time.
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Susana Campos, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
07-039
NCT ID:
NCT00520013
Start Date:
August 2007
Completion Date:
January 2013
Related Keywords:
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
- Papillary Serous Mullerian Cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
- Mixed Tumor, Mullerian
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
