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

• ClinicalTrials.gov Identifier: NCT00509665
• Recruitment Status: Completed
• First Posted: July 31, 2007
• Results First Posted: July 12, 2018
• Last Update Posted: July 12, 2018
• Sponsor: Medical University of South Carolina
• Information provided by (Responsible Party): Medical University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer	Drug: doxorubicin hydrochloride; Drug: gemcitabine hydrochloride	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Gemcitabine in Combination With Doxorubicin for Patients With Head and Neck Cancer
• Study Start Date: June 2005
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Gemcitabine+doxorubicin	Drug: doxorubicin hydrochloride; given as 25mgm2 IV on days 1 and 8 of each 21-day cycle.; Drug: gemcitabine hydrochloride; given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle

Outcome Measures

Primary Outcome Measures :

1. Response Rate [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically or cytologically confirmed head and neck cancer

  • Recurrent or progressive disease
• Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
• Must have received prior platinum-based chemotherapy regimen (cisplatin or carboplatin) with or without radiotherapy, unless the patient was deemed unsuitable for platinum-based therapy due to renal dysfunction or other clinical contraindication

Exclusion criteria:

• Known brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status (PS) ≤ 2 OR Karnofsky PS ≥ 60%
• Absolute neutrophil count ≥ 1,500/μL
• Platelets ≥ 100,000/µL
• Total bilirubin ≤ 1.5 mg/dL
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal
• Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 30 mL/min
• Females of reproductive potential must not plan on conceiving children during study treatment period and must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of the study

Exclusion criteria:

• Not pregnant or breastfeeding
• History of allergic reaction attributed to compounds of similar chemical or biological composition to gemcitabine hydrochloride or doxorubicin hydrochloride

• Lower than normal cardiac ejection fraction

  • Patients must have an echocardiogram or MUGA scan prior to the use of study drugs

• Uncontrolled intercurrent illness that would limit compliance with study requirements including, but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situation
• Clinical AIDS or known positive HIV serology

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• Recovered from prior therapy
• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• At least 30 days since prior experimental agents
• At least 4 weeks since prior radiotherapy for palliation or for the primary tumor

Exclusion criteria:

• Prior gemcitabine hydrochloride or doxorubicin hydrochloride
• Concurrent hormones or other chemotherapeutic agents, except for steroids given for adrenal failure, hormones given for non-disease-related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic
• Concurrent palliative radiotherapy
• Other concurrent investigational or commercial agents or therapies

Contacts and Locations

Locations

United States, South Carolina

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

Investigators

• Principal Investigator: Paul O'Brien; Medical University of South Carolina

More Information

Publications of Results:

Saddoughi SA, Garrett-Mayer E, Chaudhary U, O'Brien PE, Afrin LB, Day TA, Gillespie MB, Sharma AK, Wilhoit CS, Bostick R, Senkal CE, Hannun YA, Bielawski J, Simon GR, Shirai K, Ogretmen B. Results of a phase II trial of gemcitabine plus doxorubicin in patients with recurrent head and neck cancers: serum C₁₈-ceramide as a novel biomarker for monitoring response. Clin Cancer Res. 2011 Sep 15;17(18):6097-105. doi: 10.1158/1078-0432.CCR-11-0930. Epub 2011 Jul 26.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT00509665
• Other Study ID Numbers: CDR0000558049; MUSC-100838
• First Posted: July 31, 2007
• Results First Posted: July 12, 2018
• Last Update Posted: July 12, 2018
• Last Verified: June 2018

Keywords provided by Medical University of South Carolina:

recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent verrucous carcinoma of the larynx; recurrent adenoid cystic carcinoma of the oral cavity; recurrent basal cell carcinoma of the lip; recurrent mucoepidermoid carcinoma of the oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent verrucous carcinoma of the oral cavity; recurrent metastatic squamous neck cancer with occult primary; recurrent lymphoepithelioma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity; recurrent inverted papilloma of the paranasal sinus and nasal cavity; recurrent midline lethal granuloma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent salivary gland cancer; recurrent lymphoepithelioma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Gemcitabine; Doxorubicin; Liposomal doxorubicin; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antibiotics, Antineoplastic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors