Trial Outcomes & Findings for S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer (NCT NCT00100789)
NCT ID: NCT00100789
Last Updated: 2012-10-01
Results Overview
Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
0 - 3 years
Results posted on
2012-10-01
Participant Flow
Participant milestones
| Measure |
Gemcitabine and Paclitaxel
Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
Eligible
|
64
|
|
Overall Study
Eligible and Began Protocol Therapy
|
63
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
Gemcitabine and Paclitaxel
Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Progression/relapse
|
42
|
|
Overall Study
Death
|
2
|
|
Overall Study
Not protocol specified
|
5
|
|
Overall Study
Ineligible
|
3
|
|
Overall Study
Never received treatment
|
1
|
Baseline Characteristics
S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine and Paclitaxel
n=63 Participants
Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
|
|---|---|
|
Age Continuous
|
63.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Primary Site
Lip/Oral Cavity
|
20 participants
n=5 Participants
|
|
Primary Site
Nasopharynx
|
4 participants
n=5 Participants
|
|
Primary Site
Oropharynx
|
13 participants
n=5 Participants
|
|
Primary Site
Salivary glands
|
0 participants
n=5 Participants
|
|
Primary Site
Hypopharynx
|
2 participants
n=5 Participants
|
|
Primary Site
Larynx
|
16 participants
n=5 Participants
|
|
Primary Site
Paranasal Sinuses
|
3 participants
n=5 Participants
|
|
Primary Site
Other/Unknown
|
5 participants
n=5 Participants
|
|
Disease Status
Newly Diagnosed
|
5 participants
n=5 Participants
|
|
Disease Status
Persistent
|
7 participants
n=5 Participants
|
|
Disease Status
Recurrent
|
50 participants
n=5 Participants
|
|
Disease Status
Not Reported
|
1 participants
n=5 Participants
|
|
Performance Status
0
|
24 participants
n=5 Participants
|
|
Performance Status
1
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 - 3 yearsPopulation: All eligible patients who started treatment were included in this measure.
Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Gemcitabine and Paclitaxel
n=63 Participants
Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
|
|---|---|
|
Overall Survival
|
8 months
Interval 7.0 to 12.0
|
SECONDARY outcome
Timeframe: 0 - 3 yearsPopulation: All eligible patients who started treatment were included in this measure.
Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Outcome measures
| Measure |
Gemcitabine and Paclitaxel
n=63 Participants
Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
|
|---|---|
|
Progression-free Survival
|
4 months
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: 9 weeks - 3 yearsPopulation: All eligible patients with measurable disease who started treatment were included in response measures.
Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
Outcome measures
| Measure |
Gemcitabine and Paclitaxel
n=57 Participants
Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
|
|---|---|
|
Response
Unconfirmed Partial Response
|
8 participants
|
|
Response
Assessment Inadequate
|
9 participants
|
|
Response
Complete Response
|
1 participants
|
|
Response
Partial Response
|
6 participants
|
|
Response
Unconfirmed Complete Response
|
1 participants
|
|
Response
Stable/No Response
|
11 participants
|
|
Response
Increasing Disease
|
21 participants
|
SECONDARY outcome
Timeframe: Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.Population: Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Outcome measures
| Measure |
Gemcitabine and Paclitaxel
n=63 Participants
Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
|
|---|---|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Allergic reaction/hypersensitivity
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Glucose, serum-high (hyperglycemia)
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
2 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash: acne/acneiform
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Anorexia
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dehydration
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
2 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Dyspnea (shortness of breath)
|
2 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
8 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
3 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hemorrhage, pulmonary/upper respiratory - Nose
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hypotension
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
2 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
3 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Memory impairment
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (functional/symp) - Oral cav
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Muscle weakness, not d/t neuropathy - body/general
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neuropathy: motor
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neuropathy: sensory
|
3 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
7 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain - Bone
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pain-Other (Specify)
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Platelets
|
2 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Pneumonitis/pulmonary infiltrates
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
3 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
1 Participants with a given type of AE
|
|
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Vomiting
|
1 Participants with a given type of AE
|
Adverse Events
Gemcitabine and Paclitaxel
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gemcitabine and Paclitaxel
n=63 participants at risk
Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
65.1%
41/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Gastrointestinal disorders
Constipation
|
7.9%
5/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
6/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
7.9%
5/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
7.9%
5/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
7.9%
5/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Gastrointestinal disorders
Nausea
|
25.4%
16/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Gastrointestinal disorders
Vomiting
|
15.9%
10/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
General disorders
Edema: limb
|
6.3%
4/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
63.5%
40/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)
|
17.5%
11/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
General disorders
Rigors/chills
|
6.3%
4/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
33.3%
21/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
25.4%
16/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Investigations
Alkaline phosphatase
|
17.5%
11/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Investigations
Leukocytes (total WBC)
|
30.2%
19/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Investigations
Lymphopenia
|
30.2%
19/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
27.0%
17/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Investigations
Platelets
|
12.7%
8/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Investigations
Weight loss
|
14.3%
9/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
22.2%
14/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
19.0%
12/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
6.3%
4/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
6/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
25.4%
16/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
11.1%
7/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Nervous system disorders
Dizziness
|
9.5%
6/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Nervous system disorders
Neuropathy: motor
|
6.3%
4/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Nervous system disorders
Neuropathy: sensory
|
31.7%
20/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
7.9%
5/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
38.1%
24/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
15.9%
10/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
|
Vascular disorders
Hypotension
|
7.9%
5/63 • Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place