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

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ClinicalTrials.gov Identifier: NCT01554410
Recruitment Status : Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Loren Mell, MD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE March 8, 2012
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date November 5, 2020
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma
Official Title  ICMJE A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Carcinoma
Intervention  ICMJE
  • 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)
Study Arms  ICMJE Experimental: IMRT/Cisplatin/Gemcitabine
All patients get IMRT with concurrent cisplatin & gemcitabine, with the dose of gemcitabine varying according to cohort
Interventions:
  • Radiation: Intensity Modulated Radiation Therapy (IMRT)
  • Drug: Cisplatin
  • Drug: Gemcitabine
Publications * Mell LK, Xu R, Yashar CM, McHale MT, Einck JP, Mayadev J, Lee E, Binder P, Rash D, Eskander R, Heide ES, Plaxe SC, Mundt AJ, Saenz CC. Phase 1 Trial of Concurrent Gemcitabine and Cisplatin with Image Guided Intensity Modulated Radiation Therapy for Locoregionally Advanced Cervical Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Aug 1;107(5):964-973. doi: 10.1016/j.ijrobp.2020.04.019. Epub 2020 Apr 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2014)
19
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2012)
18
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01554410
Other Study ID Numbers  ICMJE UCSD 100597
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Loren Mell, MD, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Loren Mell, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP