Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Neoplasm, Unknown Primary

Treatments

Drug: bevacizumab

Drug: carboplatin

Drug: paclitaxel

Drug: erlotinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00360360

SCRI UNKPRI 19

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.