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A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma

Phase 1
18 Years
Open (Enrolling)
Cervical Carcinoma

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Trial Information

A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the maximum tolerated dose (MTD) of Gemcitabine that can be safely administered in combination with Cisplatin

Outcome Description:

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

Outcome Time Frame:

5 weeks during treatment

Safety Issue:


Principal Investigator

Loren Mell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego


United States: Institutional Review Board

Study ID:

UCSD 100597



Start Date:

August 2010

Completion Date:

August 2014

Related Keywords:

  • Cervical Carcinoma
  • Cervical
  • Carcinoma
  • Gemcitabine
  • Gemzar
  • Cisplatin
  • IMRT
  • Radiation
  • External Beam
  • Brachytherapy
  • Carcinoma
  • Uterine Cervical Neoplasms



Moores UC San Diego Cancer Center La Jolla, California  92093