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Phase II Trial of Pemetrexed Plus Gemcitabine in Patients With Advanced Non-Clear Cell Renal Cell Cancer

Phase 2
Not Enrolling
Renal Cell Carcinoma

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Trial Information

Phase II Trial of Pemetrexed Plus Gemcitabine in Patients With Advanced Non-Clear Cell Renal Cell Cancer

Pemetrexed is a chemotherapy drug that is used to treat cancer. It is given intravenously
(by IV--through a vein in your arm). It interferes with cell reproduction.

Gemcitabine is a cancer-fighting (chemotherapy) drug that is given by IV. It interferes
with the growth of cells and is used to treat cancer.

Dexamethasone has many different medical uses. It is used to treat cancer, nausea, vomiting,
inflammation, allergic reactions, and many other conditions. In this study, it is being
given to prevent rashes.

Folic acid and Vitamin B12 are vitamins given to prevent serious side effects which can
occur with chemotherapy. These side effects include diarrhea and a decrease in you red
blood cells, white blood cells, and your blood platelets.

You will be required to take folic acid and vitamin B12. You will take folic acid, by
mouth, daily beginning about 1 week before the first dose of Pemetrexed. You will continue
to take it daily until 3 weeks after the last dose of chemotherapy. Vitamin B12 will be
given as an injection into your muscle about 1 to 2 weeks before your first dose of
Pemetrexed. You will have injections of vitamin B12 about every 9 weeks until 3 weeks after
your last dose of chemotherapy.

During treatment, you will be given Pemetrexed by IV for 10 minutes, followed by Gemcitabine
by IV for 30 minutes on Day 1 of each 2-week study "cycle."

You will take Dexamethasone tablets by mouth, 2 times a day on the day before, the day of,
and the day after each dose of Pemetrexed. Dexamethasone is taken to prevent rashes. If you
could not or did not take Dexamethasone the day before and/or the day of Pemetrexed, you may
be given Dexamethasone by IV over 20 minutes, 30 minutes before the infusion of Pemetrexed.

You will have blood samples (about 4 teaspoons) drawn every week to test your bone marrow.
You will have blood samples (about 1 teaspoon) drawn every 2 weeks to make sure that your
kidneys and liver are working well. You will have a physical exam every 2 weeks before you
receive chemotherapy. You will also be asked about any medications you have been taking
since your last visit.

Once every 8 weeks or after 4 cycles of treatment, you will have the tumor(s) measured using
standard of care imaging which may include a CT scan, MRI, or a bone scan.

You will be treated for as long as you are benefiting from the therapy. You will continue
to receive treatment unless your tumor grows, intolerable side effects occur, or you develop
another illness that prevents you from continuing with the therapy. You may also be taken
off study if you fail to comply with the study requirements. If you are taken off study for
any reason, you and your doctor will discuss other treatment options at that time.

If you are taken off study, you will be asked to have the same scans as before, a physical
exam, and routine blood (about 4 teaspoons). You will be contacted every 3 months after
being off study, to get an update on your health status.

This is an investigational study. Pemetrexed and Gemcitabine are FDA approved and
commercially available. About 40 patients will take part in this study. All will be
enrolled at M. D. Anderson.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed advanced non-clear cell
RCC. Patients with locally recurrent disease are eligible. Patients with locally
advanced unresectable RCC should have measurable metastatic disease to be eligible
for the protocol. Patients with bilateral renal cancer are eligible as long as both
cancers are of non-clear cell type and patients have metastatic disease.

- Patients must have measurable disease.

- Patients with previously treated or untreated, non-threatening brain metastasis are
eligible. For previously treated patients, prior whole brain radiation therapy or
stereotactic radiosurgery must be > 3 months from initiation of current therapy and
there can be no plans for concurrent radiation while on this study. Patients who had
surgical resection for brain metastasis are eligible to enroll after they recover
from surgery.

- Life expectancy > 8 weeks

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Patients must have adequate organ and marrow function as defined below: (1)
Hemoglobin >/= 9g/dl; (2) absolute neutrophil count >/= 1,500/microL; (3) platelets
>/=100,000/microL; (4) total bilirubin (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) (SGPT) institutional upper limits of normal (uln), or exists; (6) creatinine clearance (calculated by the Cockcroft-Gault formula) >/= 45

- Patients must have recovered from any effects of surgery and/or radiation therapy and
be free of significant detectable infection.

- Female patients of childbearing potential must have a normal plasma beta human
chorionic gonadotropin (bHCG) within 24 hours prior to enrolling in the study.
Patients with an elevated bHCG will undergo appropriate evaluation to rule out
pregnancy (ie referral to OB-Gyn service, ultrasound) and if pregnancy is ruled out
and elevated bHCG is determined to be of tumor origin, patients will be permitted to
proceed on study.

- Patients of child fathering or childbearing potential must agree to practice a form
of medically acceptable birth control while on study

- Patients must give written consent prior to initiation of therapy, in keeping with
the policies of the institution. Patients with a history of major psychiatric illness
must be judged able to fully understand the investigational nature of the study and
the risks associated with the therapy. The only approved consent is attached to this

Exclusion Criteria:

- Pregnant or lactating women.

- No prior malignancy is allowed, except for non-melanoma skin cancer, in situ
carcinoma of any site, or other cancers for which the patient has been adequately
treated and disease free for 2 years.

- Patients must not have received more than 2 prior systemic therapies for RCC, but
patients should not have received any prior chemotherapy for RCC. Chemotherapy given
for other types of cancer more than 2 years prior to enrollment on this protocol is

- Patients must not be scheduled to receive any experimental drug for MRCC while on
study. Patients are permitted to be on concomitant bisphosphonates or megestrol
acetate. Patients are permitted to receive hematopoietic growth factors according to
American Society of Clinical Oncology (ASCO) guidelines.

- Patients must not have had prior radiotherapy to areas of measurable disease, unless
they have clearly progressive disease in this site, or there is measurable disease
outside the area of prior radiation. Radiotherapy, if needed for palliation, must
have been completed prior to enrollment on this study.

- Patients must not have any significant medical disease (other than the malignancy)
that, in the opinion of the investigator, would significantly increase the risk for
participation in this trial. Examples of exclusion: unstable angina pectoris, New
York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable
symptomatic cardiac arrhythmias requiring medication (subjects with controlled
chronic atrial fibrillation are eligible), myocardial infarction within the last 6
months, uncontrolled hypertension (blood pressure >160/110 on therapy) or
uncontrolled diabetes mellitus.

- Patients must not have history of other diseases, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational drug or that
might affect the interpretation of the results of the study or render the subject at
high risk from treatment complications.

- Patients unwilling to participate or unable to comply with the protocol for the
duration of the study.

- Inability or unwillingness to take corticosteroid, folic acid or vitamin B12

- Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a
5 day period (for short acting NSAIDs) or 8-day period (for long-lasting NSAIDs, such
as piroxicam)

Type of Study:


Study Design:

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

Outcome Measure:

Overall Response

Outcome Description:

Number of participants with complete or partial response. Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response: disappearance all target lesions; Partial Response: >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease: Insufficient shrinkage for partial response, or insufficient increase for progressive disease, reference smallest sum LD since treatment started.

Outcome Time Frame:

Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks

Safety Issue:


Principal Investigator

Nizar M. Tannir, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2005

Completion Date:

September 2011

Related Keywords:

  • Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Non-Clear Cell
  • Pemetrexed
  • Gemcitabine
  • LY231514
  • Alimta
  • MTA
  • Multitargeted Antifolate
  • NSC-698037
  • Gemcitabine Hydrochloride
  • Gemzar
  • RCC
  • Carcinoma
  • Carcinoma, Renal Cell



UT MD . Anderson Cancer Center Houston, Texas  77030