Phase 2
N=60
Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site
Neoplasm, Unknown Primary
Bottom Line
View on ClinicalTrials.gov: NCT00360360 ↗Enrolled (actual)
60
Serious AEs
48.3%
Results posted
Oct 2013
Primary outcome: Primary: Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death — 12.6 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- paclitaxel (Drug); carboplatin (Drug); bevacizumab (Drug); erlotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
12.6 | — |
| SECONDARY Progression-free Survival |
8 | — |
Summary
We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. There is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the EGFR pathway are effective strategies in at least a proportion.
Eligibility Criteria
Inclusion Criteria
- Biopsy proven metastatic carcinoma with the following light microscopic histologies: adenocarcinoma, poorly differentiated carcinoma(must have immunoperoxidase stains to rule out lymphoma, neuroendocrine carcinoma),or poorly differentiated squamous carcinoma.
- ECOG performance status 0-1
- No previous treatment with any systemic therapy
- Adequate kidney, liver and bone marrow function
- Be able to understand the nature of the study and give written informed consent
Exclusion Criteria
- The following specific syndromes:
- Neuroendocrine carcinoma
- Women with adenocarcinoma isolated to axillary lymph nodes
- Women with adenocarcinoma isolated to peritoneal involvement
- Carcinoma involving only one site with resectable tumors at that site
- Squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes
- Uncontrolled brain metastases and all patients with meningeal involvement
- Women pregnant or lactating
- Clinically significant cardiovascular disease
- History of myocardial infarction or stroke within 6 months
- Clinical history of hemoptysis or hematemesis
- Patients with PEG tubes or G-tubes
- Proteinuria
- History of bleeding diathesis or coagulopathy
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Data sourced from ClinicalTrials.gov (NCT00360360). 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.