A Phase II Study of Chemotherapy Treatment Based on Molecular Profiling Diagnosis for Patients With Carcinoma of Unknown Primary Site
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel
- Conditions
- Carcinoma
- Sponsor
- SCRI Development Innovations, LLC
- Enrollment
- 289
- Locations
- 20
- Primary Endpoint
- Overall Survival
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have carcinoma of unknown primary site after the following diagnostic procedures have been performed and are unrevealing of a primary site:
- •Complete medical history and physical examination,
- •Complete blood counts, chemistry profile,
- •CT scans of the chest and abdomen,
- •Directed evaluation of any symptomatic areas,
- •PET scan (recommended).
- •Patients must have biopsy-proven metastatic carcinoma, with any of the following light microscopic histologies:
- •Adenocarcinoma,
- •Poorly differentiated adenocarcinoma,
- •Poorly differentiated carcinoma (all patients with poorly differentiated carcinoma must have immunoperoxidase stains to rule out other treatable malignancies \[e.g., lymphoma, neuroendocrine carcinoma\]),
Exclusion Criteria
- •Patients with the following specific syndromes are not eligible:
- •Patients with neuroendocrine carcinoma,
- •Women with adenocarcinoma isolated to axillary lymph nodes,
- •Women with adenocarcinoma isolated to peritoneal involvement,
- •Patients with carcinoma involving only 1 site, with resectable tumor at that site, or
- •Patients with squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes.
- •Patients with uncontrolled brain metastases and all patients with meningeal metastases.
- •Patients with insufficient biopsy material available for molecular profiling assay.
- •Women who are pregnant or lactating. All females of child-bearing potential must have a negative serum or urine pregnancy tests within 7 days prior to study treatment.
- •Men and women of childbearing potential are required to use effective methods of contraception during this study and for 6 months after ending therapy.
Arms & Interventions
Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
Intervention: Paclitaxel
Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
Intervention: Carboplatin
Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
Intervention: Bevacizumab
Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
Intervention: Erlotinib
Treatment determined by physician
Other treatment determined by physician based on molecular profiling assay
Intervention: Bevacizumab
Treatment determined by physician
Other treatment determined by physician based on molecular profiling assay
Intervention: Erlotinib
Treatment determined by physician
Other treatment determined by physician based on molecular profiling assay
Intervention: Treatment determined by physician
Outcomes
Primary Outcomes
Overall Survival
Time Frame: every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months
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.
Secondary Outcomes
- Number of Participants With a Tissue of Origin Successfully Predicted by the Assay(at baseline)