Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

NCT00248560 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000445589P30CA022453WSU-D-2830WSU-HIC-120904M1F
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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 docetaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; metastatic squamous neck cancer with occult primary squamous cell carcinoma; recurrent metastatic squamous neck cancer with occult primary; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity

Outcome Measures

Primary Outcomes (1)

• Response (Complete Response [CR] + Partial Response [PR])

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  every 8 weeks for approximately 8 - 48 weeks

Secondary Outcomes (3)

• Response Duration

  Every 8 weeks

• Survival

  Every 8 weeks

• Toxicity as Measured by Number and Grade of Adverse Events

  Every 2 weeks

Study Arms (1)

Gemcitabine, docetaxel

EXPERIMENTAL

Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.

Drug: docetaxel; Drug: Gemcitabine

Interventions

docetaxel DRUG

Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.

Also known as: Taxotere

Gemcitabine, docetaxel

Gemcitabine DRUG

Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.

Also known as: Gemzar

Gemcitabine, docetaxel

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Metastatic, persistent, or recurrent disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Must have had definitive surgery and/or radiation therapy AND received at least 1, but no more than 2, chemotherapy regimens, either given as primary therapy or adjuvant therapy before or after surgery and/or radiotherapy * No active or prior CNS metastasis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * SWOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Granulocyte count \> 1,500/mm\^3 * Hemoglobin ≥ 8 g/dL * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin normal * Meets 1 of the following criteria: * Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST or ALT normal Renal * Creatinine \< 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment * No peripheral neuropathy ≥ grade 2 * No active infection requiring systemic therapy * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or any other site * No history of severe hypersensitivity reaction to study drugs or other drugs formulated with polysorbate 80 * No other serious condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior taxane or gemcitabine * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics Other * No other concurrent therapy for this disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The trial design was changed during accrual to allow for study continuation although response rate was lower than predicted. The trial was completed but it did not meet the specified end points.

Results Point of Contact

• Title: Ammar Sukari, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

sukaria@karmanos.org

313-576-8751

Study Officials

• Ammar Sukari, M.D.

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2012
• Last Updated: March 5, 2019
• Results First Posted: August 28, 2014

Record last verified: 2019-02

Locations

US (1)