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Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of California, San Diego.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Loren Mell, MD, University of California, San Diego Identifier:
First received: March 8, 2012
Last updated: December 1, 2014
Last verified: December 2014
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: 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 ]
    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 ]
    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 ]
    To determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen.

Estimated Enrollment: 19
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT/Cisplatin/Gemcitabine
All patients get IMRT with concurrent cisplatin & gemcitabine, with the dose of gemcitabine varying according to cohort
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)

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01554410

Contact: Mary Wright 858-822-5367
Contact: Erica Burbano 858-822-5398

United States, California
Moores UC San Diego Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Norma Hernandez    858-822-5036   
Principal Investigator: Loren Mell, MD         
Sub-Investigator: Arno Mundt, MD         
Sub-Investigator: Catheryn Yashar, MD         
Sub-Investigator: Steven Plaxe, MD         
Sub-Investigator: Michael McHale, MD         
Sub-Investigator: Cheryl Saenz, MD         
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Loren Mell, MD University of California, San Diego
  More Information

Responsible Party: Loren Mell, MD, Associate Professor, University of California, San Diego Identifier: NCT01554410     History of Changes
Other Study ID Numbers: UCSD 100597
Study First Received: March 8, 2012
Last Updated: December 1, 2014

Keywords provided by University of California, San Diego:
External Beam

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017