Phase 2 N=67 Treatment

S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00100789 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcome: Primary: Overall Survival — 8 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: gemcitabine (Drug); paclitaxel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SWOG Cancer Research Network
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival	8	—
SECONDARY Progression-free Survival	4	—
SECONDARY Response	1; 6; 1; 8; 11; 21	—
SECONDARY Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	1; 1; 1; 2; 2; 8	—

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
Recurrent, persistent, or newly diagnosed metastatic disease
Measurable or non-measurable disease
No active or prior CNS metastasis

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No serious organ dysfunction
No serious comorbid conditions that would preclude study treatment
No history of hypersensitivity reaction to products containing polysorbate 80
No active infection requiring systemic antibiotic therapy
No symptomatic sensory neuropathy ≥ grade 2
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
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent biologic or immunotherapy for SCCHN
No concurrent gene therapy for SCCHN

Chemotherapy

No prior chemotherapy for recurrent or newly diagnosed metastatic disease
At least 6 months since prior induction or adjuvant chemotherapy
No more than 1 prior induction or adjuvant regimen
No prior gemcitabine or taxanes as part of induction, adjuvant, or neoadjuvant chemotherapy
No other concurrent chemotherapy for SCCHN

Endocrine therapy

Not specified

Radiotherapy

At least 28 days since prior radiotherapy and recovered
No concurrent radiotherapy for SCCHN

Surgery

Not specified

Other

No other concurrent therapy for SCCHN

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00100789). 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.