Trial Outcomes & Findings for Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma (NCT NCT00184093)

NCT ID: NCT00184093

Last Updated: 2017-08-15

Results Overview

Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: Every 3 weeks from start of study until 30 days after the last dose of treatment
• Results posted on: 2017-08-15

Participant Flow

The study began recruiting in July 1999 and recruitment ended in May 2008. All participants were seen and treated at USC Norris Comprehensive Cancer Center and/or at LAC+USC Medical Center.

The study had no pre-assignment criteria. This was an open label study and all participants were given the same treatment.

Participant milestones

Measure	Gemcitabine Weekly x 6 Wks With Concurrent External Radiation Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation
Overall Study STARTED	35
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Gemcitabine Weekly x 6 Wks With Concurrent External Radiation Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	3
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Study of Gemcitabine and Concurrent Radiation Followed by Adjuvant Hysterectomy in Bulky Stage Ib and IIa Cervical Carcinoma

Baseline characteristics by cohort

Measure	Gemcitabine Weekly x 6 Wks With Concurrent External Radiation n=35 Participants Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	33 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 3 weeks from start of study until 30 days after the last dose of treatment

Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)

Outcome measures

Measure	Gemcitabine Weekly x 6 Wks With Concurrent External Radiation n=35 Participants Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation
Toxicity (Number of Participants With Serious Adverse Events)	10 Participants

SECONDARY outcome

Timeframe: Baseline to response (up to 24 months)

Participants who complete the 6 weeks of chemotherapy and radiation or who experience dose limiting toxicity or who progress at any time prior to completion of the 6 weeks of chemotherapy and radiation will be evaluable for response.

Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of nonevaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable, and nonevaluable lesions and sites must be assessed using the same technique as baseline.

Partial response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.

Outcome measures

Measure	Gemcitabine Weekly x 6 Wks With Concurrent External Radiation n=35 Participants Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation
Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)	32 Participants

Adverse Events

Gemcitabine Weekly x 6 Wks With Concurrent External Radiation

Serious events: 10 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gemcitabine Weekly x 6 Wks With Concurrent External Radiation n=35 participants at risk Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation
Hepatobiliary disorders Alkaline phosphatase	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Anorexia	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Dehydration	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Diarrhea patients without colostomy	28.6% 10/35 • Number of events 14 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Hemoglobin	5.7% 2/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hyperglycemia	2.9% 1/35 • Number of events 3 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Leukocytes (total WBC)	17.1% 6/35 • Number of events 6 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Lymphopenia	5.7% 2/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Nausea	5.7% 2/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	14.3% 5/35 • Number of events 5 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Proctitis	5.7% 2/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Rectal bleeding/hematochezia	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Rectal or perirectal pain (proctalgia)	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders SGOT (AST) (serum glutamic oxaloacetic transaminase)	5.7% 2/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders SGPT (ALT) (serum glutamic pyruvic transaminase)	14.3% 5/35 • Number of events 6 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Reproductive system and breast disorders Vaginal bleeding	5.7% 2/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Vomiting	11.4% 4/35 • Number of events 4 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.

Other adverse events

Measure	Gemcitabine Weekly x 6 Wks With Concurrent External Radiation n=35 participants at risk Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation Gemcitabine: Gemcitabine weekly x 6 wks with concurrent external radiation
Gastrointestinal disorders Abdominal pain or cramping	48.6% 17/35 • Number of events 25 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders Alkaline phosphatase	34.3% 12/35 • Number of events 16 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Skin and subcutaneous tissue disorders Alopecia	22.9% 8/35 • Number of events 8 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Anorexia	77.1% 27/35 • Number of events 44 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Musculoskeletal and connective tissue disorders Arthralgia (joint pain)	11.4% 4/35 • Number of events 5 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Ear and labyrinth disorders Auditory/Hearing-Other (not specified)	14.3% 5/35 • Number of events 5 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Constipation	68.6% 24/35 • Number of events 35 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Constitutional Symptoms-Other (not specified)	20.0% 7/35 • Number of events 8 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 7/35 • Number of events 12 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Renal and urinary disorders Creatinine	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Diarrhea patients without colostomy	94.3% 33/35 • Number of events 67 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Nervous system disorders Dizziness/lightheadedness	42.9% 15/35 • Number of events 23 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	11.4% 4/35 • Number of events 4 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Renal and urinary disorders Dysuria (painful urination)	80.0% 28/35 • Number of events 44 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Edema	17.1% 6/35 • Number of events 9 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Fatigue (lethargy, malaise, asthenia)	65.7% 23/35 • Number of events 51 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)	14.3% 5/35 • Number of events 6 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Nervous system disorders Headache	62.9% 22/35 • Number of events 36 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Renal and urinary disorders Hematuria (in the absence of vaginal bleeding)	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Hemoglobin	68.6% 24/35 • Number of events 50 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Endocrine disorders Hot flashes/flushes	8.6% 3/35 • Number of events 4 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hyperglycemia	20.0% 7/35 • Number of events 8 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders Hypoalbuminemia	5.7% 2/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hypocalcemia	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Metabolism and nutrition disorders Hyponatremia	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Hypotension	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Infections and infestations Infection without neutropenia	28.6% 10/35 • Number of events 10 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Ear and labyrinth disorders Inner ear/hearing	14.3% 5/35 • Number of events 11 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Psychiatric disorders Insomnia	5.7% 2/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Leukocytes (total WBC)	62.9% 22/35 • Number of events 39 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Lymphopenia	5.7% 2/35 • Number of events 5 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Melena/GI bleeding	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Ear and labyrinth disorders Middle ear/hearing	2.9% 1/35 • Number of events 1 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Psychiatric disorders Mood alteration-anxiety, agitation	25.7% 9/35 • Number of events 12 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Musculoskeletal and connective tissue disorders Myalgia	2.9% 1/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Nausea	88.6% 31/35 • Number of events 70 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Nervous system disorders Neuropathy-sensory	28.6% 10/35 • Number of events 11 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	65.7% 23/35 • Number of events 38 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Pain	28.6% 10/35 • Number of events 12 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Pain-Other (specify, pelvic)	25.7% 9/35 • Number of events 11 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Skin and subcutaneous tissue disorders Pigmentation changes (e.g., vitiligo)	8.6% 3/35 • Number of events 3 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Blood and lymphatic system disorders Platelets	31.4% 11/35 • Number of events 13 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Proctitis	31.4% 11/35 • Number of events 12 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Skin and subcutaneous tissue disorders Pruritus	11.4% 4/35 • Number of events 4 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Injury, poisoning and procedural complications Radiation Dermatitis	17.1% 6/35 • Number of events 8 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Skin and subcutaneous tissue disorders Rash/desquamation	28.6% 10/35 • Number of events 15 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Rectal bleeding/hematochezia	31.4% 11/35 • Number of events 12 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Rectal or perirectal pain (proctalgia)	17.1% 6/35 • Number of events 9 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
General disorders Rigors, chills	77.1% 27/35 • Number of events 46 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders SGOT (AST) (serum glutamic oxaloacetic transaminase)	48.6% 17/35 • Number of events 25 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Hepatobiliary disorders SGPT (ALT) (serum glutamic pyruvic transaminase)	60.0% 21/35 • Number of events 34 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Cardiac disorders Sinus tachycardia	5.7% 2/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Stomatitis/pharyngitis (ora/pharyngeal mucositis)	14.3% 5/35 • Number of events 6 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain (onset or exacerbation of tumor pain due to treatment)	2.9% 1/35 • Number of events 2 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Reproductive system and breast disorders Vaginal bleeding	57.1% 20/35 • Number of events 34 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
Gastrointestinal disorders Vomiting	60.0% 21/35 • Number of events 41 • Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.

Additional Information

Victoria Soto - Project Specialist

USC Norris Comprehensive Cancer Center

Phone: (323) 865-0454

Email: Victoria.Soto@med.usc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place