Neoplasms

All Conditions

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Paclitaxel, Carboplatin, Bevacizumab and Erlotinib

Other treatment determined by physician based on molecular profiling assay

Erlotinib

Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy

Treatment determined by physician

John D Hainsworth, M.D.

This is a non-randomized Phase II study. Patients determined at initial diagnosis to have a carcinoma of unknown primary site (CUP) will have their treatment selected with the use of a molecular profiling assay. The assay will be performed on paraffin-embedded tumor tissue from a biopsy specimen. Patients given specific diagnoses (e.g., lung, pancreas, colon, breast, renal cell, prostate and ovarian cancer) will receive treatment regimens of proven activity. If no specific diagnosis is made with the molecular profiling assay, empiric chemotherapy with paclitaxel, carboplatin, bevacizumab and erlotinib will be administered.

The primary objective of the study is evaluate the impact of the molecular assay prediction on the efficacy of therapy for patients with carcinoma of unknown primary site (CUP). Investigators will use tumor profiling results to direct standard, site-specific first-line therapy for patients with CUP.

Treatment Based on Molecular Profiling Diagnosis Carcinoma of Unknown Primary Site

A Phase II Study of Chemotherapy Treatment Based on Molecular Profiling Diagnosis for Patients With Carcinoma of Unknown Primary Site

Defined as the elapsed time from the start of treatment to the date of death from any cause or lost to follow-up. Participants lost to follow up were censored as of the last date known to be alive.

To evaluate the utility of the assay in identifying the tissue of origin in patients with carcinoma of unknown primary site (CUP), an archived tumor specimen was assayed upon study entry. If a tissue of origin was predicted by the assay, participants received standard site-specific therapy for that tumor type. When tissue of origin was not predicted by the assay, patients received standard empiric chemotherapy for CUP and were not followed further. If the assay was not completed due to inadequate amount of tumor in the biopsy specimen, patients were not treated on the study.

Genentech, Inc.

SCRI Development Innovations, LLC

Adverse event data were collected for 223 participants treated with at least one dose of study drug.

All Treated Patients

Of 289 patients initially enrolled, 252 had successful assays performed. 37 patients had insufficient tissue for assay and came off study.

Patients With Tumor Assays Performed

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

The focus of this study was to evaluate the ability of the 92-gene assay to successfully predict tumor tissue of origin, not to assess one particular treatment

John D. Hainsworth, MD

Patients who received assay-directed therapy for tumor types with a predicted median survival ≥ 12 months.

More Treatment Responsive

Patients who received assay-directed therapy for tumors with a predicted median survival ≤ 12 months

Less Treatment Responsive

Of 223 treated patients: 194 received assay-directed therapy; 29 received empiric CUP therapy. The 194 patients who received assay-directed therapy were separated into groups based on predicted responsiveness of the tumor type for further analysis.

Overall Survival

Biliary tract (gallbladder, bile duct)

Urothelium

Colorectum

Non-small cell lung

Pancreas

Breast

Ovary

Gastroesophageal

Kidney

Liver

Sarcoma

Cervix

Neuroendocrine

Prostate

Germ cell

Skin, squamous

Carcinoid, intestine

Mesothelioma

Thyroid

Endometrium

Melanoma

Skin, basal-cell

Lung, small-cell

Lymphoma

Head and Neck

Adrenal

unclassifiable

In 252 participants successful assays were performed. In 29 participants the amount of tumour and/or viable RNA present in the biopsy specimen was inadequate.

Patients With Successful Tumor Assays Performed

Of 252 participants analyzed, the assay correctly predicted the tissue of origin in 247 patients (98%). The predicted tissue of origin could not be determined in 5 participants (2%).

Number of Participants With a Tissue of Origin Successfully Predicted by the Assay

Subjects in this group had a successful molecular assay of biopsy tissue

All Patients With a Successful Tumor Assays Performed

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment Based on Molecular Profiling Diagnosis Carcinoma of Unknown Primary Site	NCT00737243	Carcinoma	Paclitaxel Carboplatin Bevacizumab Erlotinib Treatment deter...	18 Years -	SCRI Development Innovations, LLC
Treatment Based on Molecular Profiling Diagnosis Carcinoma of Unknown Primary Site	NCT00737243	Carcinoma	Paclitaxel Carboplatin Bevacizumab Erlotinib Treatment deter...	18 Years -	SCRI Development Innovations, LLC

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