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A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasm, Unknown Primary

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Trial Information

A Phase II Study of Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Patients With Carcinoma of Unknown Primary Site


All eligible patients will receive:

- Bevacizumab 15mg/kg IV infusion,Day 1

- Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1

- Carboplatin AUC 6.0 IV Day 1

- Erlotinib 150 mg by mouth daily

The regimen will be repeated every 21 days for a total of 4 courses. Patients will be
initially evaluated for response after completing 2 courses (6 weeks) of treatment. Patients
with an objective tumor response or stable disease will continue treatment for another 2
courses. Patients will be re-evaluated after 4 courses and those with objective tumor
response or stable disease will stop chemotherapy with paclitaxel/carboplatin and continue
treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of
12 months. During treatment with bevacizumab/erlotinib response will be evaluated every 12
weeks.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI UNKPRI 19

NCT ID:

NCT00360360

Start Date:

July 2006

Completion Date:

March 2009

Related Keywords:

  • Neoplasm, Unknown Primary
  • Neoplasm, Unknown Primary
  • Neoplasms
  • Carcinoma
  • Neoplasms, Unknown Primary

Name

Location

Northeast Georgia Medical CenterGainesville, Georgia  30501
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Oncology Hematology CareCincinnati, Ohio  45242
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Graves-Gilbert ClinicBowling Green, Kentucky  42101
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404