Uterine Cervical Cancer
Conditions
Keywords
Cervical Carcinoma
Brief summary
The purpose of this study is first to establish what is the ideal dose of gemcitabine, a chemotherapy agent, when given in combination with radiation. In addition, the investigators want to determine the side effects and the effectiveness of this combination. The investigators will also study several markers to try to identify markers or tests that will predict which patients will benefit more from this treatment.
Interventions
DRUGGemcitabine
Gemcitabine weekly x 6 wks with concurrent external radiation
Sponsors
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically confirmed bulky stage Ib or stage IIa cervical cancer. Bulky stage Ib disease is defined as tumor mass greater than 4 cms in diameter. * Cervical lesion which is measurable by physical examination. * No prior therapy for invasive cervical cancer. * GOG performance status 0-2 * Signed informed consent * Patients must have adequate: * Bone marrow function: absolute granulocyte count \> or = to 1500, platelet count \> 100,000. * Renal function: creatinine \< or = to 1.8 mg/dl * Hepatic function: bilirubin \< or = to 1.5 x normal, SGOT and alkaline phosphatase \< or = to 3 x normal
Exclusion criteria
* Patients with a history of prior malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or other cancer for which the patient has been disease free for at least five years. * Pregnant or lactating women. Women of reproductive age may not participate unless they have agreed to use an effective method of birth control. * Patients with uncontrolled infection. * Patients who are HIV positive * Patients with psychiatric or social conditions that would interfere with consent or follow-up. * Patients with any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity (Number of Participants With Serious Adverse Events) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response of Either a Complete Response (CR) or Partial Response (PR) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
The study had no pre-assignment criteria. This was an open label study and all participants were given the same treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 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
| Characteristic | Gemcitabine Weekly x 6 Wks With Concurrent External Radiation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 33 / 35 |
| serious Total, serious adverse events | 10 / 35 |
Outcome results
Primary
Toxicity (Number of Participants With Serious Adverse Events)
Summary of grade 3 or higher toxicities as per Common Toxicity Criteria version 2.0. Phase 1 and 2 Combined (N=35)
Time frame: Every 3 weeks from start of study until 30 days after the last dose of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gemcitabine Weekly x 6 Wks With Concurrent External Radiation | Toxicity (Number of Participants With Serious Adverse Events) | 10 Participants |
Secondary
Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)
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.
Time frame: Baseline to response (up to 24 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gemcitabine Weekly x 6 Wks With Concurrent External Radiation | Best Overall Response of Either a Complete Response (CR) or Partial Response (PR) | 32 Participants |