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Phase I Dose Finding Study of the Orally Bioavailable Platinum Analog Satraplatin in Combination With Abraxane (Paclitaxel Protein-bound Particles) in Advanced Cancers

Phase 1
18 Years
Not Enrolling
Advanced Cancers

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Trial Information

Phase I Dose Finding Study of the Orally Bioavailable Platinum Analog Satraplatin in Combination With Abraxane (Paclitaxel Protein-bound Particles) in Advanced Cancers

Inclusion Criteria:

- Patients must have histologically-confirmed advanced solid tumors.

- The patients must be refractory to standard therapy or have a tumor for which no
therapy with clinical benefit exists.

- Patients should have evidence of disease progression if they received a prior
therapy. This includes development of new lesions or an increase in preexisting
lesions on bone scintigraphy, CT, MRI or by physical examination. Patients in whom
the sole criterion for progression is an increase in a biochemical marker, e.g.,
carcinoembryonic antigen (CEA), or an increase in symptoms, are not eligible, with
the exception of the biochemical marker PSA (prostate specific antigen).

- No radiotherapy, treatment with cytotoxic agents, or treatment with biologic agents
within the 4 weeks prior to beginning treatment on this study (6 weeks for mitomycin
or nitrosoureas). Patients must have fully recovered from the acute toxicities of any
prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities
(returned to baseline status as noted before most recent treatment). Patients with
persisting, stable chronic toxicities from prior treatment ≤ grade 1 are eligible.

- All non-prostate cancer patients need to be at least 2 weeks off any hormonal
therapy. Prostate cancer patients need to be maintained with castrate levels of
testosterone and at least 2 weeks off any non steroidal anti-androgen,
diethylstilbestrol, or ketoconazole.

- At least 2 weeks must have elapsed from any prior surgery .

- Age ≥18 years.

- ECOG performance status ≤2 (Karnofsky ≥60%).

- Life expectancy of greater than 3 months.

- Patients must have normal organ and marrow function as defined below:

Hemoglobin ≥ 9 g/dL leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL platelets
≥100,000/mcL total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) ≤2.5 x
institutional upper limit of normal creatinine within 1.5 x ULN OR creatinine clearance
≥50 mL/min/1.73 m² for patients with creatinine levels above institutional normal.

- Women of child-bearing potential must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation and must have a negative serum or urine
pregnancy test within 1 week prior to beginning treatment on this trial. Pregnant and
nursing patients are excluded because the effects of the combination of Abraxane and
Satraplatin on a fetus or nursing child are unknown. Should a woman become pregnant
or suspect she is pregnant while participating in this study, she should inform her
treating physician immediately. Sexually active men must also use appropriate
contraception method and should not father a child while receiving therapy during
this study.

- Must be able to understand and sign a written informed consent document.

Exclusion Criteria:

- Patients who are less than 4 weeks from chemotherapy or radiotherapy, or have not
recovered from any adverse events

- Patients receiving any other investigational agents.

- Patients with known active brain metastases. Patients with treated brain metastases
are eligible if they have received radiation to the brain or surgery, more than 4
weeks prior to enrollment onto this study, and do not have progression of their
central nervous system disease radiologically or clinically. Such patients should be
off steroids for a minimum of two weeks prior to the first dose on study.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to agents used in study.

- Peripheral neuropathy ≥ Grade 2

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women are excluded from this study because the investigational agents may
have the potential for teratogenic or abortifacient effects. Because there is an
unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with these agents, breastfeeding should be discontinued if
the mother is treated.

- HIV-positive patients are ineligible because these patients are at increased risk of
lethal infections when treated with marrow-suppressive therapy and the potential
pharmacokinetic interaction between antiretroviral therapy and the investigational

- Concomitant use of certain medications that inhibit the liver microsomal enzyme
CYP3A4 and CYP2CA8/9 may result in increased levels of Satraplatin and/or Abraxane.
This increase may be clinically relevant because toxicities are related to dose and
exposure. Therefore, all herbal and alternative medications should be discontinued
while on study, these include: Hydrastis canadensis (goldenseal), Uncaria tomentosa
(cat's claw), Echinacea angustifolia roots, trifolium pratense (wild cherry),
matricaria chamomila (chamomile), and Glycyrrhiza glabra (licorice), dillapiol, and
naringenim. No concomitant use of the following drugs is allowed: cyclosporine,
diltiazem, ketoconazole, rifampin, fluconazole, delavirdine, nicardipine,
pioglitazone, and sulfonamides, St Johns Wort. Consumption of grapefruit juice is
prohibited during the study. Patients will be asked as to which medicines
(traditional or herbal) they are taking at every study visit. If possible, these
medications and/or all herbal medicines should not be restarted until 72 hours after
the last drug dose on study.

Type of Study:


Study Design:

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

Outcome Measure:

To determine a safe dose of oral Satraplatin to be administered for 5 consecutive days every week in combination with a 30 minute infusion of Abraxane administered weekly for 3 weeks out of 4 weeks.

Outcome Time Frame:

Upon completion of dose escalation and determination of MTD

Safety Issue:


Principal Investigator

Hari Deshpande, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

June 2010

Related Keywords:

  • Advanced Cancers
  • Neoplasms



Yale University, Comprehensive Cancer Center New Haven, Connecticut  06520