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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01554410
Recruitment Status : Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : November 5, 2020
Information provided by (Responsible Party):
Loren Mell, MD, University of California, San Diego

Brief Summary:
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 or disease Intervention/treatment Phase
Cervical Carcinoma Radiation: Intensity Modulated Radiation Therapy (IMRT) Drug: Cisplatin Drug: Gemcitabine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2010
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01554410

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United States, California
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
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Principal Investigator: Loren Mell, MD University of California, San Diego
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Loren Mell, MD, Associate Professor, University of California, San Diego Identifier: NCT01554410    
Other Study ID Numbers: UCSD 100597
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Keywords provided by Loren Mell, MD, University of California, San Diego:
External Beam
Additional relevant MeSH terms:
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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