Avastin and Erlotinib as First Line Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Cancer, and Papillary Serous Mullerian Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Genentech
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00520013
First received: August 22, 2007
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
The purpose of this research study is to evaluate how patients with newly diagnosed advanced ovarian, fallopian tube, primary peritoneal or papillary serous Mullerian tumor respond to Avastin and erlotinib, or Avastin alone over 1 year. These drugs have been used in the treatment of other types of cancers and information from those studies suggests that these agents may help to treat the cancers studied here.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Papillary Serous Mullerian Cancer |
Drug: Avastin Drug: erlotinib Drug: paclitaxel Drug: carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Paclitaxel
Carboplatin
Erlotinib hydrochloride
Erlotinib
Bevacizumab
U.S. FDA Resources
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To examine the progression free survival of Avastin and erlotinib (AE) or Avastin (A) as consolidation therapy at predefined time. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To examine the toxicity between the two consolidative regimens AE versus A. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess the response to CTA. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Avastin every three weeks for 1 year
|
Drug: Avastin
Given every three weeks for 1 year
Drug: paclitaxel
Given intravenously on Day 1 of each cycle for 6 cycles (each cycle lasts 21 days)
Drug: carboplatin
Given intravenously on Day 1 of each cycle for 6 cycles (a cycle lasts 21 days)
|
|
Experimental: 2
Avastin every three weeks for 1 year and erlotinib every day for one year
|
Drug: Avastin
Given every three weeks for 1 year
Drug: erlotinib
Every day for one year
Drug: paclitaxel
Given intravenously on Day 1 of each cycle for 6 cycles (each cycle lasts 21 days)
Drug: carboplatin
Given intravenously on Day 1 of each cycle for 6 cycles (a cycle lasts 21 days)
|
Detailed Description:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520013
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Genentech
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
| Principal Investigator: | Susana Campos, MD, MPH | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Susana M. Campos, MD, Medical Oncologist., Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00520013 History of Changes |
| Other Study ID Numbers: | 07-039 |
| Study First Received: | August 22, 2007 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Mixed Tumor, Mullerian Endocrine Gland Neoplasms Neoplasms by Site Neoplasms 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 Neoplasms, Complex and Mixed Neoplasms by Histologic Type Bevacizumab Carboplatin Paclitaxel Erlotinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents |
ClinicalTrials.gov processed this record on May 16, 2013