Phase I Trial of Biweekly Gemcitabine & Paclitaxel & Low-Dose Radiation for Metastatic or Recurrent Head & Neck Cancer

NCT00176241 | Terminated Phase 1

• 1 other identifier: 04-H&N-16-EL
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to establish the safety of gemcitabine, paclitaxel and low-dose radiation in recurrent, metastatic head and neck cancer through a two-stage dose escalation study, first with Gemcitabine dose escalation and then with low-dose radiation escalation. Treatment Schedule Treatment will be administered on an inpatient or outpatient basis.

• Gemcitabine:2000 to 3000mg/m2 IV (in the vein) on days 1 and 15 every 28 days over 30-60 minutes.
• Paclitaxel: 150 mg/m2 IV(in the vein)on days 1 and 15 every 28 days over 60 minutes.
• Low Dose Radiation: 50-80 cGy twice daily on days 1, 2, 15, \& 16 every 28 days at least 4 hours apart.

Conditions

Head and Neck Cancer

Keywords

head and neck; Gemcitabine; Paclitaxel; radiation; low-dose radiation; recurrent; metastatic

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  toxicity notations made during weeks 3, 5, 7 & 9 of each cycle

Secondary Outcomes (3)

• Toxicity

  weeks 3, 5, 7 & 9 of each cycle & also evaluated throughout study by weekly CBC

• Response rate

  assessed pre-study & week 8 and as needed during follow-up.

• Association of tumor markers p53, p21waf1/cip1, bcl-xL, bcl-2 & bax with response rate

  patients who consent to biopsy, obtain pre-study & 3-24 hrs after completion of 4th fraction of radiation, evaluated by immunohistochemistry

Study Arms (1)

1

EXPERIMENTAL

Drug: gemcitabine; Drug: paclitaxel; Radiation: radiation

Interventions

gemcitabine DRUG

2000-3000mg/m2 IV on days 1 \& 15

Also known as: Gemzar

1

paclitaxel DRUG

150 mg/m2 IV on days 1 \& 15

1

radiation RADIATION

50-80 cGy on days 1,2,15,16

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yrs old or greater \& have histologically or cytologically proven metastatic or recurrent head \& neck cancer \& have failed at least 1 prior, but not more than 3 chemotherapeutic regimen. Patients who have recurred after previous surgery and/or radiation may participate in this trial, \& patients may have had prior neoadjuvant or adjuvant therapy. No restriction is placed on the # of cycles (beyond 1) of prior therapy, however, patients must not have received the combination of Gemcitabine \& Paclitaxel previously.
• Patients with known brain metastases are eligible for this trial if disease has been treated \& the patient is clinically stable \& documented by a stable or improved pretreatment CT or MRI of the brain to evaluate CNS disease within 28 days prior to registration.
• Patients must have measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). Measurable disease must be assessed within 28 days prior to registration \& non-measurable must be assessed within 42 days prior to registration. Pleural effusions, ascites \& lab parameters are not acceptable as only evidence of disease.
• Patients must have progressed after at least 1 prior chemotherapeutic regimen. Prior biologic therapy or radiation is permitted; however, at least 2 wks must have elapsed since completion of prior therapy \& patients must have recovered from all associated toxicities at time of registration.
• At least 3 wks must have elapsed since surgery (thoracic or other major surgeries) \& patients must have recovered from all associated toxicities at time of registration. Measurable or non-measurable disease must be present outside the area of surgical resection.
• Patients must have an ANC 1,500/µl \& platelet count 100,000/µl obtained within 28 days prior to registration.
• Patients must have adequate hepatic function documented by a serum bilirubin 1.5 x institutional ULN \& LFTs (SGOT or SGPT) 2.5 x the institutional ULN obtained within 28 days prior to registration.
• All patients with pulmonary metastasis must have an FEV1 of \> 1000 ml/min obtained within 28 days prior to registration \& must have PFTs with DLCO.
• All patients must have a Zubrod Performance Status of 0,1 or 2.
• Peripheral neuropathy, if present, must be Grade 1.
• Patients must be informed of investigational nature of this study \& must sign \& give written informed consent in accordance with institutional \& federal guidelines.

You may not qualify if:

• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 yrs.
• Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to study entry \& for duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Patients taking drugs that are strong inducers of the enzyme CYP3A4 including anticonvulsants (i.e., phenytoin, phenobarbital, carbamazepine, or primidone) \& rifampin OR strong inhibitors of CYP3A4 (clarithromycin, itraconazole, and ketoconazole) will be excluded from this study. Patients must be off these medications for 2 wks in order to participate in this trial.

Sponsors & Collaborators

• Susanne Arnold: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Links

• Markey Cancer Center clinical trials search

MeSH Terms

Conditions

Head and Neck Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

Gemcitabine; Paclitaxel; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Physical Phenomena

Study Officials

• Susanne Arnold, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: December 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2008
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

US (1)