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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine weekly x 6 wks with concurrent external radiation | Experimental | Gemcitabine 350 mg/m2 IV weekly x 6 weeks with concurrent external radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine weekly x 6 wks with concurrent external radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Every 3 weeks from start of study until 30 days after the last dose of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynda Roman, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
The study had no pre-assignment criteria. This was an open label study and all participants were given the same treatment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Count of Participants | Participants | Every 3 weeks from start of study until 30 days after the last dose of treatment |
|
|
Adverse events were collected beginning cycle 1 and continued throughout the study until 30 days after the last dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain or cramping | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Soto - Project Specialist | USC Norris Comprehensive Cancer Center | (323) 865-0454 | Victoria.Soto@med.usc.edu |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Baseline to response (up to 24 months) |
| Withdrawal by Subject |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Posted | Count of Participants | Participants | Baseline to response (up to 24 months) |
|
|
|
| 0 |
| 35 |
| 10 |
| 35 |
| 33 |
| 35 |
| Anorexia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhea patients without colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rectal bleeding/hematochezia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rectal or perirectal pain (proctalgia) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
|
| SGPT (ALT) (serum glutamic pyruvic transaminase) | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vaginal bleeding | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Alkaline phosphatase | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Arthralgia (joint pain) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Auditory/Hearing-Other (not specified) | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constitutional Symptoms-Other (not specified) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Creatinine | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhea patients without colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dizziness/lightheadedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dysuria (painful urination) | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hematuria (in the absence of vaginal bleeding) | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hot flashes/flushes | Endocrine disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypoalbuminemia | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Infection without neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Inner ear/hearing | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Melena/GI bleeding | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Middle ear/hearing | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
|
| Mood alteration-anxiety, agitation | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nausea | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pain-Other (specify, pelvic) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pigmentation changes (e.g., vitiligo) | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Radiation Dermatitis | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rectal bleeding/hematochezia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rectal or perirectal pain (proctalgia) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Rigors, chills | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
|
| SGPT (ALT) (serum glutamic pyruvic transaminase) | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Stomatitis/pharyngitis (ora/pharyngeal mucositis) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Tumor pain (onset or exacerbation of tumor pain due to treatment) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | Systematic Assessment |
|
| Vaginal bleeding | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |