Phase 2 N=59 Randomized Treatment

Avastin +/- Erlotinib Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Advanced Ovarian, Fallopian Tube, Primary Peritoneal Cancer & Papillary Serous or Clear Cell Mullerian Tumors

Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Cancer · Papillary Serous Mullerian Tumor · Clear Cell Mullerian Tumor

Bottom Line

View on ClinicalTrials.gov: NCT00520013 ↗

Enrolled (actual)

Serious AEs

52.1%

Results posted

Jul 2015

Primary outcome: Primary: Consolidation Progression-Free Survival — 13.3; 18.9 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bevacizumab (Drug); erlotinib (Drug); paclitaxel (Drug); carboplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Dana-Farber Cancer Institute
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Consolidation Progression-Free Survival	13.3; 18.9	—
PRIMARY Consolidation Treatment-related Toxicity Rate	30.4; 72.0	—
SECONDARY Consolidation Objective Response Rate	0.65; .60	—

Summary

The purpose of this research study is to evaluate how patients with newly diagnosed advanced ovarian, fallopian tube, primary peritoneal cancer and papillary serous or clear cell mullerian tumors respond to consolidation therapy with 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.

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00520013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.