Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma
This study is currently recruiting participants.
Verified March 2012 by University of California, San Diego
Sponsor:
University of California, San Diego
Information provided by (Responsible Party):
Loren Mell, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01554410
First received: March 8, 2012
Last updated: March 14, 2012
Last verified: March 2012
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Purpose
The primary objective of the study is to identify the highest dose of gemcitabine that can be given safely with cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer. The investigators hypothesis is that IMRT will reduce gastrointestinal and hematologic toxicity, permitting escalating doses of gemcitabine to be feasibly delivered in patients with locally advanced cervical cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Carcinoma |
Radiation: Intensity Modulated Radiation Therapy (IMRT) Drug: Cisplatin Drug: Gemcitabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma |
Resource links provided by NLM:
Further study details as provided by University of California, San Diego:
Primary Outcome Measures:
- Establish the maximum tolerated dose (MTD) of Gemcitabine that can be safely administered in combination with Cisplatin [ Time Frame: 5 weeks during treatment ] [ Designated as safety issue: Yes ]To determine the maximum tolerated dose (MTD) of weekly gemcitabine that can be administered with concurrent weekly cisplatin and pelvic intensity modulated radiation therapy (IMRT) in women with locally advanced cervical cancer
Secondary Outcome Measures:
- Number of Participants with Acute Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 30 Days post-treatment ] [ Designated as safety issue: Yes ]To quantify acute treatment-related adverse events that occur within 30 days of completing protocol treatment.
- Number of Participants with Progression-Free Survival as a Measure of Response [ Time Frame: Up to 12 months post treatment ] [ Designated as safety issue: No ]To determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.
| Estimated Enrollment: | 18 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Radiation: Intensity Modulated Radiation Therapy (IMRT)
45 Gy in 25 daily fractions (1.8 Gy per fraction)
Drug: Cisplatin
Weekly infusion of 40 mg/m2 x 5 weeks (70 mg maximum)
Drug: Gemcitabine
Weekly infusion x 5 weeks at escalating dose levels (50mg/m2, 75mg/m2, 100mg/m2, and 125mg/m2)
Many studies have investigated multiagent chemotherapy as a means of intensifying treatment. The results of such trials indicate that gemcitabine has considerable activity against cervical cancer when given with cisplatin/RT, however, it is quite toxic. The predominant toxicities are gastrointestinal and hematologic. Methods to reduce gastrointestinal and hematologic toxicity during chemoradiotherapy could mitigate this toxicity and take advantage of the therapeutic benefits of gemcitabine
IMRT is an advanced radiation therapy delivery technique that reduces the amount of radiation given to normal tissues and may therefore reduce unwanted side effects. IMRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer cells and other areas, such as lymph nodes. IMRT does this by using computers to design the best way to aim radiation at the tumor(s), while still delivering a radiation dose comparable to standard radiation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis: Histologically-proven, invasive primary carcinoma of the cervix.
- Disease Status: Stage IB2-IVA cervical cancer or stage I with biopsy-proven pelvic node metastases, positive surgical margins, or parametrial extension based upon standard diagnostic workup, including:
- History/physical examination
- Examination under anesthesia (if indicated)
- Biopsy
- Intravenous pyelogram and/or cystoscopy (if indicated)
- Colonoscopy, sigmoidoscopy, or rigid proctoscopy (if indicated)
- PA and lateral chest x-ray or chest CT
- CT or MRI of the pelvis
- PET, PET/CT, or PET/CT simulation (encouraged)
- Performance Level: Karnofsky Performance Status ≥ 60 - Peripheral ≥ ANC 1500/uL
- Platelet count ≥ 100,000/uL (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
- Serum creatinine ≤ 1.5 mg/dl
- Bilirubin (sum of conjugated + unconjugated) < 1.5 mg/dl, and
- SGPT (ALT) < 1.5 x upper limit of normal (ULN) for age, and
- SGOT (AST) < 1.5 x upper limit of normal (ULN) for age
Exclusion Criteria:
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events.(Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.
- Concomitant Medications, if taken within the last 28 days.
- Growth factor(s): Growth factors that support platelet or white cell number or function must not have been administered within the past 28 days.
- Erythropoietic drug(s): Erythropoietin or related hormones must not have been administered within the past 28 days.
- Infection: Patients who have an uncontrolled infection.
- Evidence of para-aortic lymphadenopathy or distant metastases
- Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years.
- Prior systemic chemotherapy within the last three years.
- Prior radiotherapy to the pelvis
- Allergic to iodinated contrast if undergoing a contrast enhanced CT scan of the pelvis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554410
Contacts
| Contact: Sara-Jane Onyeama | 858-822-5356 | sonyeama@ucsd.edu |
| Contact: Meaghan Stirn | 858-822-5354 | mstirn@ucsd.edu |
Locations
| United States, California | |
| Moores UC San Diego Cancer Center | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Carrie Marcus 858-822-5036 cjrichardson@ucsd.edu | |
| Principal Investigator: Loren Mell, MD | |
| Sub-Investigator: Arno Mundt, MD | |
| Sub-Investigator: Catheryn Yashar, MD | |
| Sub-Investigator: Mary Ann Rose, MD | |
| Sub-Investigator: Steven Plaxe, MD | |
| Sub-Investigator: Michael McHale, MD | |
| Sub-Investigator: Cheryl Saenz, MD | |
Sponsors and Collaborators
University of California, San Diego
Investigators
| Principal Investigator: | Loren Mell, MD | University of California, San Diego |
More Information
Additional Information:
No publications provided
| Responsible Party: | Loren Mell, MD, Assistant Professor, Director Division, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01554410 History of Changes |
| Other Study ID Numbers: | UCSD 100597 |
| Study First Received: | March 8, 2012 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
Cervical Carcinoma Gemcitabine Gemzar Cisplatin |
IMRT Radiation External Beam Brachytherapy |
Additional relevant MeSH terms:
|
Carcinoma Uterine Cervical Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Gemcitabine Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013