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 - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Genentech Beth Israel Deaconess Medical Center Brigham and Women's Hospital Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00520013

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 II

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:

MedlinePlus related topics: Cancer Ovarian Cancer

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:	August 2010
Estimated Primary Completion Date:	August 2010 (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 Campos, MD, MPH, 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:	January 14, 2010
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 February 09, 2012