Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site
Condition: Neoplasm, Unknown Primary
MeSH terms: Neoplasms, Unknown Primary
Intervention: paclitaxel; carboplatin; bevacizumab; erlotinib
Intervention description: Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1; Carboplatin AUC 6.0 IV Day 1; Bevacizumab 15mg/kg IV infusion,Day 1; Erlotinib 150 mg by mouth daily
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoplasm, Unknown Primary

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.