Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: doxorubicin hydrochloride; Drug: gemcitabine hydrochloride

• Registration Number: NCT00509665
• Lead Sponsor: Medical University of South Carolina

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with doxorubicin works in treating patients with recurrent or progressive head and neck cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2007-07-30
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2018-05-04
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-13
• Last Update Submitted: 2018-06-13
• Results First Posted: 2018-07-12
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine+doxorubicin	gemcitabine hydrochloride	-
Gemcitabine+doxorubicin	doxorubicin hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Response Rate	Every 6 weeks from the time of initial treatment for up to 8 months	Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above.

Secondary Outcome Measures

Name	Time	Method
Correlation of Cytotoxicity With Apoptosis in Cancer Cells	prior to first dose of drug and every 6 weeks for up to 6 months
Duration of Response	Every 6 weeks for up to 8 months
Progression-free Survival	Through the end of follow up, for an average of 8 months
Number of Patients Who Had Greater Than Grade 2 Toxicity	from time of initial treatment until end of study, an average of 6 months
Overall Survival	From the time of initial therapy until the time of death.
Correlation of Cytoxocity With Cell-cycle Arrest	prior to first dose of drug and every 6 weeks up to 6 months

Trial Locations

Locations (1)

Hollings Cancer Center at Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States