Trial Outcomes & Findings for Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (NCT NCT00639769)

Last Updated: 2012-09-14

Results Overview

Number of patients in each response category according to RECIST criteria: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

6 weeks after last chemotherapy treatment

Results posted on

2012-09-14

Participant Flow

Recruitment period = 2/27/2002 through 5/9/2006

A total of 41 people signed consent to take part in this study, of those, 1 was determined to be ineligible.

Participant milestones

Participant milestones
Measure	Therapeutic Intervention Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
Overall Study STARTED	40
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Therapeutic Intervention Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
Overall Study Death	2
Overall Study Adverse Event	7
Overall Study Lack of Efficacy	1
Overall Study Disease progression	26
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapeutic Intervention n=40 Participants Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	58 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks after last chemotherapy treatment

Population: Analysis was per protocol (7 patients did not receive a full cycle of treatment, and 1 patient was censored for incomplete records)

Outcome measures

Outcome measures
Measure	Therapeutic Intervention n=32 Participants Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
Patient Response Partial Response	11 participants
Patient Response Progressive Disease	15 participants
Patient Response Stable Disease	6 participants
Patient Response Complete response	0 participants

SECONDARY outcome

Timeframe: 6 weeks after last chemotherapy

Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death

Outcome measures

Outcome measures
Measure	Therapeutic Intervention n=40 Participants Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
Number of Patients With Each Worst-grade Toxicity No. of patients with worst-grade toxicity of 1	2 participants
Number of Patients With Each Worst-grade Toxicity No. of patients with worst-grade toxicity of 2	12 participants
Number of Patients With Each Worst-grade Toxicity No. of patients with worst-grade toxicity of 3	21 participants
Number of Patients With Each Worst-grade Toxicity No. of patients with worst-grade toxicity of 4	10 participants
Number of Patients With Each Worst-grade Toxicity No. of patients with worst-grade toxicity of 5	1 participants

Adverse Events

Therapeutic Intervention

Serious events: 27 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Therapeutic Intervention n=40 participants at risk Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
Gastrointestinal disorders Abdominal distention	2.5% 1/40 • Number of events 1
Gastrointestinal disorders Abdominal pain	2.5% 1/40 • Number of events 1
Metabolism and nutrition disorders Anorexia	5.0% 2/40 • Number of events 2
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	2.5% 1/40 • Number of events 1
General disorders Chills	2.5% 1/40 • Number of events 1
Hepatobiliary disorders Cholelithiasis	2.5% 1/40 • Number of events 1
Investigations Creatinine increased	5.0% 2/40 • Number of events 2
Metabolism and nutrition disorders Dehydration	32.5% 13/40 • Number of events 13
Nervous system disorders Depressed level of consciouness	2.5% 1/40 • Number of events 1
Gastrointestinal disorders Diarrhea	27.5% 11/40 • Number of events 11
Gastrointestinal disorders Dysphagia - esophageal (related to radiation)	2.5% 1/40 • Number of events 1
Gastrointestinal disorders Dysphagia, esophagitis, odynophagai	7.5% 3/40 • Number of events 3
Infections and infestations Facial cellulitis	5.0% 2/40 • Number of events 2
General disorders Fatigue	5.0% 2/40 • Number of events 2
Blood and lymphatic system disorders Febrile neutropenia	5.0% 2/40 • Number of events 2
General disorders Fever	5.0% 2/40 • Number of events 2
Nervous system disorders Headache	2.5% 1/40 • Number of events 1
Investigations Hemoglobin decreased	7.5% 3/40 • Number of events 3
Metabolism and nutrition disorders Hyponatremia	2.5% 1/40 • Number of events 1
Vascular disorders Hypotension	7.5% 3/40 • Number of events 3
Gastrointestinal disorders Illeus	2.5% 1/40 • Number of events 1
Gastrointestinal disorders Infected gastrocutaneous fistula	2.5% 1/40 • Number of events 1
Investigations Leukocytes (WBC 1.3)	5.0% 2/40 • Number of events 2
Musculoskeletal and connective tissue disorders Muscle weakness	2.5% 1/40 • Number of events 1
Gastrointestinal disorders Nausea	25.0% 10/40 • Number of events 10
Investigations Neutrophil count decreased	15.0% 6/40 • Number of events 6
Investigations Platelet count decreased	5.0% 2/40 • Number of events 2
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.0% 2/40 • Number of events 2
General disorders Post-nasal drip	2.5% 1/40 • Number of events 1
Musculoskeletal and connective tissue disorders Right shoulder pain	5.0% 2/40 • Number of events 2
Gastrointestinal disorders Small bowel obstruction	2.5% 1/40 • Number of events 1
Musculoskeletal and connective tissue disorders Subacute fx of L1 vertebral body	2.5% 1/40 • Number of events 1
Vascular disorders Thromboembolism	5.0% 2/40 • Number of events 2
Infections and infestations Urosepsis	2.5% 1/40 • Number of events 1
Gastrointestinal disorders Vomiting	32.5% 13/40 • Number of events 13
General disorders Weakness	5.0% 2/40 • Number of events 2
Investigations White blood cell decrease	2.5% 1/40 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Barbara Murphy, M.D.

Vanderbilt-Ingram Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place