Phase 3 N=198 Randomized Treatment

Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site

Neoplasms, Unknown Primary

Bottom Line

View on ClinicalTrials.gov: NCT00193596 ↗

Enrolled (actual)

198

Serious AEs

57.1%

Results posted

May 2013

Primary outcome: Primary: Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death — 7.4; 8.5 months

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Etoposide (Drug); Gemcitabine (Drug); Irinotecan (Drug); Paclitaxel (Drug); Carboplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SCRI Development Innovations, LLC
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death	7.4; 8.5	—
SECONDARY Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease	3.3; 5.3	—

Summary

In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.

Eligibility Criteria

Inclusion Criteria

To be included in this study, you must meet the following criteria:

Carcinoma of unknown primary site
Biopsy-proven metastatic carcinoma
Able to perform activities of daily living with minimal assistance
No previous treatment with any systemic therapy
Measurable or evaluable disease
Adequate bone marrow, liver and kidney function
Understand the nature of this study and give written informed consent

Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

Age < 18 years
Uncontrolled brain metastases and meningeal involvement
Other uncontrolled malignancies
Women pregnant or lactating
Recent history of significant cardiovascular disease
Severe or uncontrolled systemic disease
Other significant clinical disorder
Clinically active interstitial lung disease

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00193596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.